ThrombosisPhase 2NCT02981472
A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation
A Phase 2 study testing Apixaban, Vitamin K Antagonist (VKA) and Low Molecular Weight Heparin (LMWH) in people with Thrombosis, run by Bristol-Myers Squibb at 46 sites in 14 countries.
Trial summary
To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation. Read more about this study
- Who is it for?
- Ages 28 days to 17 years
- Conditions the study is for
- Thrombosis
- What is being tested?
- Apixaban, Vitamin K Antagonist (VKA) and Low Molecular Weight Heparin (LMWH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 46 sitesin 14 countries
- Study dates
- 19 Jan 2017to 18 Oct 2021
- Phase
- Phase 2
- 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 28 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and Females, 28 days to < 18 years of age, inclusive
- Congenital or acquired heart diseases requiring chronic anticoagulation for thromboprophylaxis (eg, single ventricle physiology including all 3 stages of palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and pulmonary hypertension)
- Eligible participants include those who newly start anticoagulants and those who are currently on VKA or LMWH or other anticoagulants for thromboprophylaxis
- Able to tolerate enteral medication [eg, by mouth, nasogastric tube, or gastric tube]
- Participants 28 days to < 3 months must be able to tolerate oral/nasogastric tube (NGT)/gastric tube (GT) feeds for at least 5 days prior to randomization
Who cannot join
- Recent thromboembolic events less than 6 months prior to enrollment
- Weight < 3 kg
- Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment
- Artificial heart valves and mechanical heart valves
- Known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von Willebrand disease, etc.)
- Active bleeding at the time of enrollment
Show all 11Show fewer
- Any major bleeding other than perioperative in the preceding 3 months
- Known intracranial congenital vascular malformation or tumor
- Confirmed diagnosis of a GI ulcer
- Known antiphospholipid syndrome (APS).
- Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
46 sites in 14 countries.
46 sites in 14 countries
United States14 sites
Local Institution - 0013
Ann Arbor, Michigan, 48109
Childrens Healthcare Of Atlanta
Atlanta, Georgia, 30322
Children'S Hospital Colorado
Aurora, Colorado, 80045
Local Institution - 0009
Boston, Massachusetts, 02115
Local Institution - 0012
Charleston, South Carolina, 29425
Local Institution - 0006
Cincinnati, Ohio, 45229
Local Institution - 0011
Houston, Texas, 77030-2399
Local Institution - 0008
Indianapolis, Indiana, 46202
Childrens Mercy Hospital
Kansas City, Missouri, 64108
University Of California San Diego
La Jolla, California, 92093-0641
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Children'S Hospital
Phoenix, Arizona, 85016
Primary Children's Hospital
Salt Lake City, Utah, 84113
Local Institution - 0055
Seattle, Washington, 98105
Brazil5 sites
Local Institution - 0020
Campinas, São Paulo, 13060-080
Local Institution - 0022
Curitiba, Paraná, 80250-060
Instituto De Cardiologia Do Rio Grande Do Sul
Porto Alegre, Rio Grande do Sul, 90620-001
Instituto de Pesquisa PENSI
São Paulo, 01227-200
Universidade Federal De Sao Paulo
São Paulo, 04024-002
Mexico4 sites
Local Institution - 0044
León, Guanajuato, 37000
Local Institution - 0018
Mexico City, Mexico City, 04530
Local Institution - 0019
Mexico City, Mexico City, 06720
Local Institution - 0016
Mexico City, Mexico City, 14080
Russia4 sites
Local Institution
Kazan', 420012
Local Institution
Kemerovo, 650002
Local Institution - 0057
Novosibirsk, 630055
Local Institution - 0062
Yekaterinburg, 620134
Germany3 sites
Local Institution - 0002
Freiburg im Breisgau, 79106
Local Institution - 0004
Hamburg, 20246
Local Institution - 0003
München, 80636
Italy3 sites
Local Institution - 0028
Bologna, 40138
Local Institution - 0027
Milan, 20097
Local Institution - 0026
Rome, Roma, 00165
Spain3 sites
Local Institution - 0049
Barcelona, 08950
Local Institution
Madrid, 28007
Local Institution - 0048
Madrid, 28046
United Kingdom3 sites
Local Institution - 0042
Bristol, Somerset, BS2 8BJ
Local Institution - 0040
Leicester, Leicestershire, LE3 9QP
Local Institution
Manchester, M13 9WL
Israel2 sites
Local Institution - 0047
Petah Tikva, 0
Local Institution - 0046
Tel HaShomer, 52620
About this study
Official title: A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.
- Conditions
- Thrombosis
- Being tested
- Apixaban, Vitamin K Antagonist (VKA), Low Molecular Weight Heparin (LMWH)
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
Specified dose on specified days
Vitamin K Antagonist (VKA)Drug
Also called Warfarin
Specified dose on specified days
Low Molecular Weight Heparin (LMWH)Drug
Also called Enoxaparin
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | Not described Receives: Drug: Apixaban |
| LMWH/VKA | Active comparator | Not described Receives: Drug: Vitamin K Antagonist (VKA); Drug: Low Molecular Weight Heparin (LMWH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC).
Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology.
CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room.
Measured: From first dose to 2 days after last dose (Up to approximately 12 months)
Secondary outcomes (14)
The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death
The number of participants with thromboembolic events (intra-cardiac, shunt, inside Fontan pathway, pulmonary embolism (PE), stroke, other arterial or venous thromboembolic events, etc.) and thromboembolic event-related death detected by imaging or clinical diagnosis.
Death and thromboembolic events are adjudicated by a blinded, independent events adjudication committee (EAC)
Measured: From randomization to 2 days after last dose (Up to approximately 12 months)
The Number of Participants With Adjudicated Major Bleeding
The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).
Major bleeding is defined as bleeding that satisfies one or more of the following criteria:
- fatal bleeding
- clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period
- bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS
- bleeding that requires surgical intervention in an operating suite, including interventional radiology
Measured: From first dose to 2 days after last dose (Up to approximately 12 months)
The Number of Participants With Adjudicated CRNM Bleeding
The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).
CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria:
- overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition
- bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
Measured: From first dose to 2 days after last dose (Up to approximately 12 months)
The Number of Participants With All Adjudicated Bleeding
The number of participants with all adjudicated bleeding events
Measured: From first dose to 2 days after last dose (Up to approximately 12 months)
The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding
The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding.
Measured: From first dose to 2 days after last dose (Up to approximately 12 months)
The Number of Participant Deaths in the Study
The number of participant deaths in the study.
Measured: From first dose to 2 days after last dose (Up to approximately 12 months)
Maximum Observed Concentration (Cmax)
Measured: From first dose up to 6 months after first dose
Trough Observed Concentration (Cmin)
Measured: From first dose up to 6 months after first dose
Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))
Measured: From first dose up to 6 months after first dose
Time of Maximum Observed Concentration (Tmax)
Measured: From first dose up to 6 months after first dose
Anti-FXa Activity
Anti-FXa Activity was measured to assess participant plasma apixaban levels.
125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below.
Measured: From first dose up to 6 months after first dose
Chromogenic FX Assay (Apparent FX Level)
Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban.
125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below.
Measured: From first dose up to 6 months after first dose
The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)
Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.
PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot).
Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems.
Measured: from randomization up to 12 months after randomization
Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score
Subjects' quality of life was measured using the KIDCLOT instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.
KIDCLOT Parent inventory uses a 5 point Likert scale from 1 (N/A), 2 (Never), 3 (Rarely), 4 ( Now and then), 5 (Often). Child inventory uses a 4 point Likert scale 1 (N/A), 2 (Never), 3 (Now and then), 5 (Always). Values are scores as follows 1=0, 2=1, 3=2, 4=3, 5=4. Score interpretation is 0 to 100 percent IMPACT of anticoagulation on a child's life therefore, higher scores indicates a more negative effect.
Measured: from randomization up to 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start19 Jan 2017
- Primary completion18 Oct 2021
- Study completion18 Oct 2021
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 Bristol-Myers SquibbThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pediatric Heart Network, Pfizer
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981472
- Sponsor's protocol ID
- CV185-362
- Other IDs
- 2016-001247-39, 2016
- Status last verified
- Sep 2022
- First submitted
- 18 Nov 2016
- Last updated
- 3 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Payne RM, Burns KM, Glatz AC, Male C, Donti A, Brandao LR, Balling G, VanderPluym CJ, Bu'Lock F, Kochilas LK, Stiller B, Cnota JF 2nd, Rahkonen O, Khan A, Adorisio R, Stoica S, May L, Burns JC, Saraiva JFK, McHugh KE, Kim JS, Rubio A, Chia-Vazquez NG, Meador MR, Dyme JL, Reedy AM, Ajavon-Hartmann T, Jarugula P, Carlson-Taneja LE, Mills D, Wheaton O, Monagle P. Apixaban for Prevention of Thromboembolism in Pediatric Heart Disease. J Am Coll Cardiol. 2023 Dec 12;82(24):2296-2309. doi: 10.1016/j.jacc.2023.10.010.
PubMed 38057072
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
- ClinicalTrials.gov ID
- NCT02981472
- Acronym / sponsor ID
- CV185-362
- Conditions
- Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Pediatric Heart Network, Pfizer
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Posted 18 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: Apixaban |
| LMWH/VKA | Active comparator | Drug: Vitamin K Antagonist (VKA), Drug: Low Molecular Weight Heparin (LMWH) |
Who may qualify
- Ages
- 28 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males and Females, 28 days to < 18 years of age, inclusive
- Congenital or acquired heart diseases requiring chronic anticoagulation for thromboprophylaxis (eg, single ventricle physiology including all 3 stages of palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and pulmonary hypertension)
- Eligible participants include those who newly start anticoagulants and those who are currently on VKA or LMWH or other anticoagulants for thromboprophylaxis
- Able to tolerate enteral medication [eg, by mouth, nasogastric tube, or gastric tube]
- Participants 28 days to < 3 months must be able to tolerate oral/nasogastric tube (NGT)/gastric tube (GT) feeds for at least 5 days prior to randomization
Key exclusion criteria (11 listed)
- Recent thromboembolic events less than 6 months prior to enrollment
- Weight < 3 kg
- Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment
- Artificial heart valves and mechanical heart valves
- Known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von Willebrand disease, etc.)
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 |
|---|---|---|
| ApixabanAlso: EliquisSpecified dose on specified days | Drug | Apixaban |
| Vitamin K Antagonist (VKA)Also: WarfarinSpecified dose on specified days | Drug | LMWH/VKA |
| Low Molecular Weight Heparin (LMWH)Also: EnoxaparinSpecified dose on specified days | Drug | LMWH/VKA |
Primary outcome
Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
Time frame: From first dose to 2 days after last dose (Up to approximately 12 months)
The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC). Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology. CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room.
14 secondary outcomes
The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death
Time frame: From randomization to 2 days after last dose (Up to approximately 12 months)
The Number of Participants With Adjudicated Major Bleeding
Time frame: From first dose to 2 days after last dose (Up to approximately 12 months)
The Number of Participants With Adjudicated CRNM Bleeding
Time frame: From first dose to 2 days after last dose (Up to approximately 12 months)
The Number of Participants With All Adjudicated Bleeding
Time frame: From first dose to 2 days after last dose (Up to approximately 12 months)
The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding
Time frame: From first dose to 2 days after last dose (Up to approximately 12 months)
The Number of Participant Deaths in the Study
Time frame: From first dose to 2 days after last dose (Up to approximately 12 months)
Maximum Observed Concentration (Cmax)
Time frame: From first dose up to 6 months after first dose
Trough Observed Concentration (Cmin)
Time frame: From first dose up to 6 months after first dose
Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))
Time frame: From first dose up to 6 months after first dose
Time of Maximum Observed Concentration (Tmax)
Time frame: From first dose up to 6 months after first dose
Anti-FXa Activity
Time frame: From first dose up to 6 months after first dose
Chromogenic FX Assay (Apparent FX Level)
Time frame: From first dose up to 6 months after first dose
The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)
Time frame: from randomization up to 12 months after randomization
Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score
Time frame: from randomization up to 12 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38057072Payne RM, Burns KM, Glatz AC, Male C, Donti A, Brandao LR, Balling G, VanderPluym CJ, Bu'Lock F, Kochilas LK, Stiller B, Cnota JF 2nd, Rahkonen O, Khan A, Adorisio R, Stoica S, May L, Burns JC, Saraiva JFK, McHugh KE, Kim JS, Rubio A, Chia-Vazquez NG, Meador MR, Dyme JL, Reedy AM, Ajavon-Hartmann T, Jarugula P, Carlson-Taneja LE, Mills D, Wheaton O, Monagle P. Apixaban for Prevention of Thromboembolism in Pediatric Heart Disease. J Am Coll Cardiol. 2023 Dec 12;82(24):2296-2309. doi: 10.1016/j.jacc.2023.10.010.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Thrombosis
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
46 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apixaban, Vitamin K Antagonist (VKA) and Low Molecular Weight Heparin (LMWH) in people with Thrombosis, run by Bristol-Myers Squibb at 46 sites in 14 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 5 inclusion and 11 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 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Brazil, Mexico, Russia, Germany and 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 18 May 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?
Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events (time frame: From first dose to 2 days after last dose (Up to approximately 12 months)). 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 NCT02981472, 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 3 Oct 2022.