Spinal Cord InjuriesPhase 4rivaroxabanNCT02970773
Absorption of Rivaroxaban in Patients With Cervical Spinal Cord Injury
A Phase 4 study testing Rivaroxaban Oral Tablet in people with Spinal Cord Injuries and Thromboembolism, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The primary objective of this study is to investigate the pharmacokinetic and -dynamic properties of rivaroxaban after oral administration in cervical spinal cord injury (SCI) individuals. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Thromboembolism
- What is being tested?
- Rivaroxaban Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Dec 2017to 7 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Motor complete tetraplegia for at least 3 months
- Age from 18 to 74 years
- Body mass index (BMI) from 18 to 35kg/m2
- Informed consent as documented by signature
Who cannot join
- Any anti-coagulation therapy (apart from rivaroxaban for second objective)
- Hypersensitivity or allergy to factor Xa inhibitors
- Acute bacterial endocarditis
- Bleeding disorder
- Clinically relevant active bleeding
- Gastrointestinal ulcer or tumor
Show all 14Show fewer
- Hepatic dysfunction with increased bleeding risk
- Renal failure / patients undergoing dialysis
- Pregnancy and breast feeding
- Gastrectomy, biliopancreatic diversion, resection or re-routing of small intestines
- Feeding tube
- Recent blood donation
- Abnormalities of laboratory values: alanine-aminotransferase (ALAT), aspartate-aminotransferase (ASAT), gamma-glutamyl transferase (gammaGT), alkalic phosphatase (AP), bilirubin, amylase, lipase, cystatin C, creatinine, white blood cell count, haemoglobin, platelet count, prothrombin time, aPTT, fibrinogen, thrombin time, factors II,V,VII and X
- Use of therapeutic or recreational drugs influencing plasmatic coagulation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre Nottwil
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Prospective, Non-randomized, Open-label, Mono-centric, Cohort Study on the Absorption of Oral Rivaroxaban in Patients With a Cervical Spinal Cord Injury
The primary objective of this study is to investigate the pharmacokinetic and -dynamic properties of rivaroxaban after oral administration in cervical spinal cord injury (SCI) individuals.
The secondary objective of this study is to determine the steady-state rivaroxaban activity in cervical SCI individuals under long-term therapy.
Read more
Primary Objective In-house patients will be informed concerning the study and informed consent will be collected.
During the screening day, in- / exclusion criteria will be assessed and a blood samples will be taken for assessing haematology, clinical chemistry and coagulation parameters. Furthermore, the evaluation day will be scheduled.
On the evaluation day, in- / exclusion criteria will be re-assessed. A venous catheter will be introduced into a forearm or lower leg of each participant for the collection of blood at the specified time points. Skin inspection for subcutaneous bleeding will be performed and vital signs will be recorded. A blood sample will be taken for assessing haematology, clinical chemistry and coagulation parameters.
Single administration of oral rivaroxaban in the form of Xarelto® 10mg tablets (Bayer Schering Pharma, Berlin, Germany).
Rivaroxaban concentrations will be determined from plasma samples taken before, 30min after and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours after rivaroxaban administration. Rivaroxaban activity will be determined from plasma samples taken before, 30min after and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours after rivaroxaban administration using a factor Xa inhibition test and measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT).
Skin inspection for subcutaneous bleeding and measurements of vital signs will be performed 30min and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours after rivaroxaban administration.
Secondary Objective Patients under long-term rivaroxaban therapy will be recruited during their annual check-up visit at the Swiss Paraplegic Centre. In- / exclusion criteria will be assessed, and the patients will be informed concerning the study and informed consent will be collected.
Blood samples will be taken for assessing haematology, clinical chemistry and coagulation parameters, and skin inspection for subcutaneous bleeding and measurements of vital signs will be performed.
A blood sample (4.3ml citrated venous blood) will be taken for assessing the primary and secondary outcome parameters.
- Conditions
- Spinal Cord Injuries, Thromboembolism
- Being tested
- Rivaroxaban Oral Tablet
- Medical subject headings
- Spinal Cord Injuries, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban Oral TabletDrug
oral application of Xarelto
| Study group | Role | What they receive |
|---|---|---|
| rivaroxaban | Other | Rivaroxaban Oral Tablet Receives: Drug: Rivaroxaban Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
rivaroxaban plasma level
Measured: before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration
Secondary outcomes (2)
inhibition of factor XII
Measured: before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration
prothrombin time
Measured: before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start4 Dec 2017
- Primary completion7 Dec 2018
- Study completion7 Dec 2018
Why it stopped: insufficient recruitment; sponsor-investigator has left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Peter Felleiter, MD PhD, Principal investigator, Swiss Parapelgic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970773
- Sponsor's protocol ID
- 2013-21
- Acronym
- rivaroxaban
- Status last verified
- Jan 2019
- First submitted
- 18 Nov 2016
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomized, Open-label, Mono-centric, Cohort Study on the Absorption of Oral Rivaroxaban in Patients With a Cervical Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02970773
- Acronym / sponsor ID
- rivaroxaban / 2013-21
- Conditions
- Spinal Cord Injuries, Thromboembolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: insufficient recruitment; sponsor-investigator has left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to investigate the pharmacokinetic and -dynamic properties of rivaroxaban after oral administration in cervical spinal cord injury (SCI) individuals.
The secondary objective of this study is to determine the steady-state rivaroxaban activity in cervical SCI individuals under long-term therapy.
Primary Objective In-house patients will be informed concerning the study and informed consent will be collected.
During the screening day, in- / exclusion criteria will be assessed and a blood samples will be taken for assessing haematology, clinical chemistry and coagulation parameters. Furthermore, the evaluation day will be scheduled.
On the evaluation day, in- / exclusion criteria will be re-assessed. A venous catheter will be introduced into a forearm or lower leg of each participant for the collection of blood at the specified time points. Skin inspection for subcutaneous bleeding will be performed and vital signs will be recorded. A blood sample will be taken for assessing haematology, clinical chemistry and coagulation parameters.
Single administration of oral rivaroxaban in the form of Xarelto® 10mg tablets (Bayer Schering Pharma, Berlin, Germany).
Rivaroxaban concentrations will be determined from plasma samples taken before, 30min after and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours after rivaroxaban administration. Rivaroxaban activity will be determined from plasma samples taken before, 30min after and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours after rivaroxaban administration using a factor Xa inhibition test and measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT).
Skin inspection for subcutaneous bleeding and measurements of vital signs will be performed 30min and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours after rivaroxaban administration.
Secondary Objective Patients under long-term rivaroxaban therapy will be recruited during their annual check-up visit at the Swiss Paraplegic Centre. In- / exclusion criteria will be assessed, and the patients will be informed concerning the study and informed consent will be collected.
Blood samples will be taken for assessing haematology, clinical chemistry and coagulation parameters, and skin inspection for subcutaneous bleeding and measurements of vital signs will be performed.
A blood sample (4.3ml citrated venous blood) will be taken for assessing the primary and secondary outcome parameters.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rivaroxaban | Other | Drug: Rivaroxaban Oral TabletRivaroxaban Oral Tablet |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Motor complete tetraplegia for at least 3 months
- Age from 18 to 74 years
- Body mass index (BMI) from 18 to 35kg/m2
- Informed consent as documented by signature
Key exclusion criteria (14 listed)
- Any anti-coagulation therapy (apart from rivaroxaban for second objective)
- Hypersensitivity or allergy to factor Xa inhibitors
- Acute bacterial endocarditis
- Bleeding disorder
- Clinically relevant active bleeding
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 |
|---|---|---|
| Rivaroxaban Oral Tabletoral application of Xarelto | Drug | rivaroxaban |
Primary outcome
rivaroxaban plasma level
Time frame: before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration
2 secondary outcomes
inhibition of factor XII
Time frame: before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration
prothrombin time
Time frame: before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Peter Felleiter, MD PhD principal investigator
Swiss Parapelgic Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban Oral Tablet in people with Spinal Cord Injuries and Thromboembolism, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
rivaroxaban plasma level (time frame: before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2019.