ThrombosisPhase 3UNIVERSENCT02846532
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
A Phase 3 study testing Rivaroxaban and Acetylsalicylic Acid in people with Thrombosis, run by Janssen Research & Development, LLC at 42 sites in 10 countries.
Trial summary
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within… Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Thrombosis
- What is being tested?
- Rivaroxaban and Acetylsalicylic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 42 sitesin 10 countries
- Study dates
- 16 Nov 2016to 16 Jul 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant must be considered to be clinically stable by the investigator and able to tolerate oral or enteral administration of a suspension formulation and oral/enteral feedings
- Satisfactory initial post-Fontan transthoracic echocardiographic Screening as defined in the Post-Fontan Echocardiographic Examination Research Protocol
- Parent/legally acceptable representative must sign an informed consent form (ICF) and child assent will also be provided, if applicable, according to local requirements
Who cannot join
- Evidence of thrombosis, including those that are asymptomatic confirmed by post-Fontan procedure transthoracic echocardiogram, or other imaging techniques, during the Screening period of the study
- History of gastrointestinal disease or surgery associated with clinically relevant impaired absorption
- History of or signs/symptoms suggestive of protein-losing enteropathy
- Active bleeding or high risk for bleeding contraindicating antiplatelet or anticoagulant therapy, including a history of intracranial bleeding
- Platelet count less than (<)50*10^9/Liters (L) at Screening
- Estimated glomerular filtration rate (eGFR) <30 milliliters per minute per 1.73 meter square (mL/min/1.73m^2)
- Known clinically significant liver disease
Trial locations and contacts
42 sites in 10 countries.
42 sites in 10 countries
United States17 sites
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Cincinnati, Ohio
Study site
Durham, North Carolina
Study site
Gainesville, Florida
Study site
Hershey, Pennsylvania
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Iowa City, Iowa
Study site
Los Angeles, California
Study site
Memphis, Tennessee
Study site
Milwaukee, Wisconsin
Study site
Minneapolis, Minnesota
Study site
Oak Lawn, Illinois
Study site
Omaha, Nebraska
Study site
Philadelphia, Pennsylvania
Study site
Salt Lake City, Utah
Spain5 sites
Study site
A Coruña
Study site
Barcelona
Study site
Bilbao
Study site
Madrid
Study site
Valencia
Japan4 sites
Study site
Fukuoka
Study site
Kitakyushu-shi
Study site
Setagaya Ku
Study site
Shizuoka
Canada3 sites
Study site
Montreal, Quebec
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Netherlands3 sites
Study site
Leiden
Study site
Rotterdam
Study site
Utrecht
About this study
Official title: A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram [mg] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram [mg/kg]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.
Read the detailed description
Part A: This part includes a 12-day Initial PK, PD, and Safety Assessment Period. Participants in Part A will not participate in Part B. Randomization in Part B of this study will begin once the cumulative data from the Initial PK, PD, and Safety Assessment Period in Part A are deemed acceptable by the Independent Data Monitoring Committee. Part A of the study will consist of an up to 21-day Screening Period, a 12-day Initial PK, PD, and Safety Assessment Period, a 12-month Open-Label Treatment Period, and a 30-day Follow-Up phone contact. Part B: Participants will be randomly assigned to two treatment groups and randomization ratio will be 2:1 for rivaroxaban and ASA. ASA will be used as control. There will be an up to a 21-day Screening Period, a 12 month Open-Label Treatment Period and a 30-day Follow-Up phone contact.
- Conditions
- Thrombosis
- Being tested
- Rivaroxaban, Acetylsalicylic Acid
- Keywords
- Thromboembolism, Fontan Procedure, Children
- Medical subject headings
- Thrombosis, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Participants will receive oral suspension containing rivaroxaban 1 milligram per milliliter (mg/ml) twice daily in Part A and Part B. Following total daily doses of Rivaroxaban will be administered based on the weight of the participants: 7 to <8 kilogram (kg) will receive 2.2 milligram (mg); 8 to <10 kg will receive 3.2 mg; 10 to<12 kg will receive 3.4 mg; 12 to <20 will receive 4.0 mg and 20 to <30 will receive 5.0 mg.
Acetylsalicylic AcidDrug
Participants will receive 5 milligram per kilogram (mg/kg) of acetylsalicylic acid once daily up to 12 months in Part B.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Not described Receives: Drug: Rivaroxaban |
| Acetylsalicylic Acid | Experimental | Not described Receives: Drug: Acetylsalicylic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic)
Thrombotic event was defined as the appearance of a new thrombotic burden within the cardiovascular system on either routine surveillance or clinically indicated imaging, or the occurrence of a clinical event known to be strongly associated with thrombus (such as cardioembolic stroke, pulmonary embolism). The event included ischemic stroke, pulmonary embolism, venous thrombosis, arterial/intracardiac thrombosis, and other thrombosis.
Measured: Up to 12 months
Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose)
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 1: 0.5-1.5 hours postdose
Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose)
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 1: 1.5-4 hours postdose
Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose)
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 4: Up to 3 hours predose
Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose)
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 4: 0.5-1.5 hours postdose
Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose)
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 4: 1.5-4 hours postdose
Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose)
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 4: 6-8 hours postdose
Plasma Concentration of Rivaroxaban at Month 3 (Up to 3 Hours Predose)
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Month 3: Up to 3 hours predose
Plasma Concentration of Rivaroxaban at Month 3 (0.5-1.5 Hours Postdose)
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Month 3: 0.5-1.5 hours postdose
Plasma Concentration of Rivaroxaban at Month 3 (2.5-4 Hours Postdose)
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Month 3: 2.5-4 hours postdose
Percentage of Participants With Bleeding Events
Bleeding events were categorized into major, clinically relevant non-major bleeding (CRNM), and trivial bleeding events. Major bleeding: overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more; or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults; or occurring in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; or contributing to death. CRNM bleeding: overt bleeding not meeting the criteria for major bleeding but associated with: Medical intervention, or Unscheduled contact with a physician, cessation of study treatment, or Discomfort for the subject such as pain, or Impairment of activities of daily life. Trivial bleeding: any other overt bleeding event that does not meet criteria for CRNM bleeding.
Measured: Up to 12 months
Absolute Prothrombin Time (PT) at Day 1 (0.5-1.5 Hours Postdose)
Absolute prothrombin time was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 1: 0.5-1.5 hours postdose
Absolute PT at Day 1 (1.5-4 Hours Postdose)
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 1: 1.5-4 hours postdose
Absolute PT at Day 4 (Up to 3 Hours Predose)
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here.
Measured: Day 4: Up to 3 hours predose
Absolute PT at Day 4 (0.5-1.5 Hours Postdose)
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 4: 0.5-1.5 hours postdose
Absolute PT at Day 4 (1.5-4 Hours Postdose)
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 4: 1.5-4 hours postdose
Absolute PT at Day 4 (6-8 Hours Postdose)
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 4: 6-8 hours postdose
Absolute PT at Month 3 (Up to 3 Hours Predose)
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Month 3: Up to 3 hours predose
Absolute PT at Month 3 (0.5-1.5 Hours Postdose)
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Month 3: 0.5-1.5 hours postdose
Absolute PT at Month 3 (2.5-4 Hours Postdose)
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Month 3: 2.5-4 hours postdose
Activated Partial Thromboplastin Time (aPTT) at Day 1 (0.5-1.5 Hours Postdose)
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 1: 0.5-1.5 hours postdose
aPTT at Day 1 (1.5-4 Hours Postdose)
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and average of the participants included in the given time-range is presented here.
Measured: Day 1: 1.5-4 hours postdose
aPTT at Day 4 (Up to 3 Hours Predose)
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 4: Up to 3 hours predose
aPTT at Day 4 (0.5-1.5 Hours Postdose)
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here.
Measured: Day 4: 0.5-1.5 hours postdose
aPTT at Day 4 (1.5-4 Hours Postdose)
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average for the participants included in the given time-range is presented here.
Measured: Day 4: 1.5-4 hours postdose
aPTT at Day 4 (6-8 Hours Postdose)
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 4: 6-8 hours postdose
aPTT at Month 3 (Up to 3 Hours Predose)
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Month 3: Up to 3 hours predose
aPTT at Month 3 (0.5-1.5 Hours Postdose)
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Month 3: 0.5-1.5 hours postdose
aPTT at Month 3 (2.5-4 Hours Postdose)
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Month 3: 2.5-4 hours postdose
Anti-FXa at Day 1 (0.5-1.5 Hours Postdose)
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 1: 0.5-1.5 hours postdose
Anti-FXa at Day 1 (1.5-4 Hours Postdose)
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 1: 1.5-4 hours postdose
Anti-FXa at Day 4 (6-8 Hours Postdose)
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Day 4: 6-8 hours postdose
Anti-FXa at Month 3 (Up to 3 Hours Predose)
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Month 3: Up to 3 hours predose
Anti-FXa at Month 3 (0.5-1.5 Hours Postdose)
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Month 3: 0.5-1.5 hours postdose
Anti-FXa at Month 3 (2.5-4 Hours Postdose)
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Measured: Month 3: 2.5-4 hours postdose
Secondary outcomes (1)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as those adverse events (AEs) that occurred from the first day of study drug to the last day of study drug + 2 days inclusive. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start16 Nov 2016
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846532
- Sponsor's protocol ID
- CR108075
- Other IDs
- 39039039CHD3001, 2015-002610-76, 2015
- Acronym
- UNIVERSE
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2016
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Publications
McCrindle BW, Michelson AD, Van Bergen AH, Suzana Horowitz E, Pablo Sandoval J, Justino H, Harris KC, Jefferies JL, Miriam Pina L, Peluso C, Nessel K, Lu W, Li JS; UNIVERSE Study Investigators *. Thromboprophylaxis for Children Post-Fontan Procedure: Insights From the UNIVERSE Study. J Am Heart Assoc. 2021 Nov 16;10(22):e021765. doi: 10.1161/JAHA.120.021765. Epub 2021 Sep 24.
PubMed 34558312
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure
- ClinicalTrials.gov ID
- NCT02846532
- Acronym / sponsor ID
- UNIVERSE / CR108075
- Conditions
- Thrombosis
- Keywords
- Thromboembolism, Fontan Procedure, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Posted 28 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram [mg] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram [mg/kg]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.
Detailed description
Part A: This part includes a 12-day Initial PK, PD, and Safety Assessment Period. Participants in Part A will not participate in Part B. Randomization in Part B of this study will begin once the cumulative data from the Initial PK, PD, and Safety Assessment Period in Part A are deemed acceptable by the Independent Data Monitoring Committee. Part A of the study will consist of an up to 21-day Screening Period, a 12-day Initial PK, PD, and Safety Assessment Period, a 12-month Open-Label Treatment Period, and a 30-day Follow-Up phone contact. Part B: Participants will be randomly assigned to two treatment groups and randomization ratio will be 2:1 for rivaroxaban and ASA. ASA will be used as control. There will be an up to a 21-day Screening Period, a 12 month Open-Label Treatment Period and a 30-day Follow-Up phone contact.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: Rivaroxaban |
| Acetylsalicylic Acid | Experimental | Drug: Acetylsalicylic Acid |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participant must be considered to be clinically stable by the investigator and able to tolerate oral or enteral administration of a suspension formulation and oral/enteral feedings
- Satisfactory initial post-Fontan transthoracic echocardiographic Screening as defined in the Post-Fontan Echocardiographic Examination Research Protocol
- Parent/legally acceptable representative must sign an informed consent form (ICF) and child assent will also be provided, if applicable, according to local requirements
Key exclusion criteria (7 listed)
- Evidence of thrombosis, including those that are asymptomatic confirmed by post-Fontan procedure transthoracic echocardiogram, or other imaging techniques, during the Screening period of the study
- History of gastrointestinal disease or surgery associated with clinically relevant impaired absorption
- History of or signs/symptoms suggestive of protein-losing enteropathy
- Active bleeding or high risk for bleeding contraindicating antiplatelet or anticoagulant therapy, including a history of intracranial bleeding
- Platelet count less than (<)50*10^9/Liters (L) at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanParticipants will receive oral suspension containing rivaroxaban 1 milligram per milliliter (mg/ml) twice daily in Part A and Part B. Following total daily doses of Rivaroxaban will be administered based on the weight of the participants: 7 to <8 kilogram (kg) will receive 2.2 milligram (mg); 8 to <10 kg will receive 3.2 mg; 10 to<12 kg will receive 3.4 mg; 12 to <20 will receive 4.0 mg and 20 to <30 will receive 5.0 mg. | Drug | Rivaroxaban |
| Acetylsalicylic AcidParticipants will receive 5 milligram per kilogram (mg/kg) of acetylsalicylic acid once daily up to 12 months in Part B. | Drug | Acetylsalicylic Acid |
Primary outcome
Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic)
Time frame: Up to 12 months
Thrombotic event was defined as the appearance of a new thrombotic burden within the cardiovascular system on either routine surveillance or clinically indicated imaging, or the occurrence of a clinical event known to be strongly associated with thrombus (such as cardioembolic stroke, pulmonary embolism). The event included ischemic stroke, pulmonary embolism, venous thrombosis, arterial/intracardiac thrombosis, and other thrombosis.
Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose)
Time frame: Day 1: 0.5-1.5 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose)
Time frame: Day 1: 1.5-4 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose)
Time frame: Day 4: Up to 3 hours predose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose)
Time frame: Day 4: 0.5-1.5 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose)
Time frame: Day 4: 1.5-4 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose)
Time frame: Day 4: 6-8 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Plasma Concentration of Rivaroxaban at Month 3 (Up to 3 Hours Predose)
Time frame: Month 3: Up to 3 hours predose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Plasma Concentration of Rivaroxaban at Month 3 (0.5-1.5 Hours Postdose)
Time frame: Month 3: 0.5-1.5 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Plasma Concentration of Rivaroxaban at Month 3 (2.5-4 Hours Postdose)
Time frame: Month 3: 2.5-4 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Percentage of Participants With Bleeding Events
Time frame: Up to 12 months
Bleeding events were categorized into major, clinically relevant non-major bleeding (CRNM), and trivial bleeding events. Major bleeding: overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more; or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults; or occurring in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; or contributing to death. CRNM bleeding: overt bleeding not meeting the criteria for major bleeding but associated with: Medical intervention, or Unscheduled contact with a physician, cessation of study treatment, or Discomfort for the subject such as pain, or Impairment of activities of daily life. Trivial bleeding: any other overt bleeding event that does not meet criteria for CRNM bleeding.
Absolute Prothrombin Time (PT) at Day 1 (0.5-1.5 Hours Postdose)
Time frame: Day 1: 0.5-1.5 hours postdose
Absolute prothrombin time was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Absolute PT at Day 1 (1.5-4 Hours Postdose)
Time frame: Day 1: 1.5-4 hours postdose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Absolute PT at Day 4 (Up to 3 Hours Predose)
Time frame: Day 4: Up to 3 hours predose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here.
Absolute PT at Day 4 (0.5-1.5 Hours Postdose)
Time frame: Day 4: 0.5-1.5 hours postdose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Absolute PT at Day 4 (1.5-4 Hours Postdose)
Time frame: Day 4: 1.5-4 hours postdose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Absolute PT at Day 4 (6-8 Hours Postdose)
Time frame: Day 4: 6-8 hours postdose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Absolute PT at Month 3 (Up to 3 Hours Predose)
Time frame: Month 3: Up to 3 hours predose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Absolute PT at Month 3 (0.5-1.5 Hours Postdose)
Time frame: Month 3: 0.5-1.5 hours postdose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Absolute PT at Month 3 (2.5-4 Hours Postdose)
Time frame: Month 3: 2.5-4 hours postdose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Activated Partial Thromboplastin Time (aPTT) at Day 1 (0.5-1.5 Hours Postdose)
Time frame: Day 1: 0.5-1.5 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
aPTT at Day 1 (1.5-4 Hours Postdose)
Time frame: Day 1: 1.5-4 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and average of the participants included in the given time-range is presented here.
aPTT at Day 4 (Up to 3 Hours Predose)
Time frame: Day 4: Up to 3 hours predose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
aPTT at Day 4 (0.5-1.5 Hours Postdose)
Time frame: Day 4: 0.5-1.5 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here.
aPTT at Day 4 (1.5-4 Hours Postdose)
Time frame: Day 4: 1.5-4 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average for the participants included in the given time-range is presented here.
aPTT at Day 4 (6-8 Hours Postdose)
Time frame: Day 4: 6-8 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
aPTT at Month 3 (Up to 3 Hours Predose)
Time frame: Month 3: Up to 3 hours predose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
aPTT at Month 3 (0.5-1.5 Hours Postdose)
Time frame: Month 3: 0.5-1.5 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
aPTT at Month 3 (2.5-4 Hours Postdose)
Time frame: Month 3: 2.5-4 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Anti-FXa at Day 1 (0.5-1.5 Hours Postdose)
Time frame: Day 1: 0.5-1.5 hours postdose
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Anti-FXa at Day 1 (1.5-4 Hours Postdose)
Time frame: Day 1: 1.5-4 hours postdose
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Anti-FXa at Day 4 (6-8 Hours Postdose)
Time frame: Day 4: 6-8 hours postdose
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Anti-FXa at Month 3 (Up to 3 Hours Predose)
Time frame: Month 3: Up to 3 hours predose
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Anti-FXa at Month 3 (0.5-1.5 Hours Postdose)
Time frame: Month 3: 0.5-1.5 hours postdose
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Anti-FXa at Month 3 (2.5-4 Hours Postdose)
Time frame: Month 3: 2.5-4 hours postdose
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
1 secondary outcome
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34558312McCrindle BW, Michelson AD, Van Bergen AH, Suzana Horowitz E, Pablo Sandoval J, Justino H, Harris KC, Jefferies JL, Miriam Pina L, Peluso C, Nessel K, Lu W, Li JS; UNIVERSE Study Investigators *. Thromboprophylaxis for Children Post-Fontan Procedure: Insights From the UNIVERSE Study. J Am Heart Assoc. 2021 Nov 16;10(22):e021765. doi: 10.1161/JAHA.120.021765. Epub 2021 Sep 24.
- ERF update upload receiptLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
42 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban and Acetylsalicylic Acid in people with Thrombosis, run by Janssen Research & Development, LLC at 42 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Spain, Japan, Belgium, Brazil and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic) (time frame: Up to 12 months). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02846532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.