Antiphospholipid SyndromePhase 3NCT02926170
Rivaroxaban for Patients With Antiphospholipid Syndrome
A Phase 3 study testing Rivaroxaban and acenocumarol in people with Antiphospholipid Syndrome, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Long-term anticoagulation is widely used for secondary thromboprophylaxis in the antiphospholipid syndrome (APS) due to the high risk of recurrent events. Currently anticoagulation with vitamin K antagonists (VKAs) is the standard of care but have unpredictable pharmacodynamic properties that requiere monitoring for… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Antiphospholipid Syndrome
- What is being tested?
- Rivaroxaban and acenocumarol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteSpain
- Study dates
- 13 Mar 2013to 31 Dec 2017
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with thrombotic antiphsopholipd syndrome
- Treated with acenocumarol for a minimum period of 6 months
- Positivity for Lupus anticoagulant and/or anti-cardiolipin or anti-B2GPI antibodies IgG or IgM≥40
Who cannot join
- Major haemorrhage (cerebral or gastrointestinal) within the previous 6 months
- Neurosurgery within the previous 4 weeks
- Any surgery within the previous 10 days
- Active peptic ulcus
- ALT or GPT >120 UI/mL non-lupus related in the previous 30 days
- Platelets <30x10E9 in the previous 30 days
Show all 10Show fewer
- Recent diagnosed malignancy
- Any criteria listed in the summary of the produt characterisitcs (SPC)
- Renal disease with a creatinine clearance <30 mL/min or with a known uncontrolled renal disease
- Concomitant administration of drugs that could interfere with CYP3A4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rivaroxaban Versus Acenocumarol for Secondary Thromboprophylaxis in Patients With Antiphospholipid Syndrome: a Randomized, Prospective, Phase III Study. Analysis of Stratification Prognostic Factors
Long-term anticoagulation is widely used for secondary thromboprophylaxis in the antiphospholipid syndrome (APS) due to the high risk of recurrent events. Currently anticoagulation with vitamin K antagonists (VKAs) is the standard of care but have unpredictable pharmacodynamic properties that requiere monitoring for dose adjustment. Rivaroxaban, an orally active direct factor Xa inhibitor, has been shown to be effective and safe compared with warfarin for the treatment of venous thromboembolism and non valvular atrial fibrillation in major RCTs. No studies had been published in APS.The aim of the study is to investigate the efficacy and safety of rivaroxaban in preventing recurrent thrombosis in patients with APS compared with acenocoumarol
Read the detailed description
This is a phase 3 randomized, multicenter, non-inferiority open-label RCT. 190 eligible APS patients with arterial or venous thrombotic history receiving acenocoumarol will be stratified according the presence of SLE and venous/arterial thrombotic history and randomized (1:1) either to continue vitamin K antagonists (standard of care, normalized ratio (INR) 2-3 or 2.5 to 3.5 in those with recurrent thrombotic episodes) or to switch to rivaroxaban (20 mg/day). The primary efficacy outcome is the development of any thrombotic event during the study period. Secondary efficacy outcomes include time to thrombosis, type of thrombosis (arterial or venous), overall causes of death, evaluation of a prognostic biomarker panel of recurrent thrombosis. The primary safety outcome will be major bleeding. Secondary safety outcomes include any adverse event and minor bleeding.
- Conditions
- Antiphospholipid Syndrome
- Being tested
- Rivaroxaban, acenocumarol
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called XARELTO
Rivaroxaban will be started at 20 mg/day. Dose will be adjusted according to Cr Clearance. Cr Clearance 30-49 ml/min will receive 15 mg/day.
acenocumarolDrug
Also called SINTROM
Doses will be adjusted according to INR
| Study group | Role | What they receive |
|---|---|---|
| rivaroxaban | Experimental | Rivaroxaban 20 mg per day Receives: Drug: Rivaroxaban |
| acenocumarol | Active comparator | INR adjusted dose Receives: Drug: acenocumarol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developement of a new thrombotic event (arterial or venous), confirmed by appropiate imaging studies
Stroke or transient ischemic attack, myocardial infarction, peripheral arterial thrombosis, cerebral vein thrombosis, deep-vein thrombosis, or pulmonary embolism) that was confirmed by adjudication
Measured: 36 months
Incidence of major bleeding
Major bleeding is defined as clinically overt bleeding associated with any of the following: fatal bleeding causing death, involvement of a critical anatomic site (intracranial, spinal, intraocular, pericardial, articular, retroperitoneal, or intramuscular with compartment syndrome) or need for surgery or angiographic intervention to stop haemorrhage, fall in haemoglobin concentration of at least 20 g/L in 24 hours, and/or requiring non-planned transfusion of ≥2 units of packed red blood cells or whole blood
Measured: 36 months
Secondary outcomes (5)
Incidence of any treatment-Emergent Adverse events
- all adverse events; ii) serious adverse events (SAE); iii) all bleeding events; iv) overall causes of death
Measured: 36 months
Death due to thrombotic events
Death as result of a thrombotic event
Measured: 36 months
Time to the first thrombotic event
Time (months) from the treatment onset up to the thrombotic event
Measured: 36 months
Location of thrombotic events
Location (arterial or venous) whenre the thrombotic event occurred
Measured: 36 months
Evaluation of a prognostic biomarker panel
Measuremnt of D-dimer, P-selectine and Von-willebrand factor
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start13 Mar 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josefina Cortes, MD,pHD, Principal investigator, Hospital Universitari Vall d'Hebron Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926170
- Sponsor's protocol ID
- 2010-019764-36
- Status last verified
- May 2018
- First submitted
- 3 Oct 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban Versus Acenocumarol for Secondary Thromboprophylaxis in Patients With Antiphospholipid Syndrome: a Randomized, Prospective, Phase III Study. Analysis of Stratification Prognostic Factors
- ClinicalTrials.gov ID
- NCT02926170
- Acronym / sponsor ID
- 2010-019764-36
- Conditions
- Antiphospholipid Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 13 Mar 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Oct 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.
Long-term anticoagulation is widely used for secondary thromboprophylaxis in the antiphospholipid syndrome (APS) due to the high risk of recurrent events. Currently anticoagulation with vitamin K antagonists (VKAs) is the standard of care but have unpredictable pharmacodynamic properties that requiere monitoring for dose adjustment. Rivaroxaban, an orally active direct factor Xa inhibitor, has been shown to be effective and safe compared with warfarin for the treatment of venous thromboembolism and non valvular atrial fibrillation in major RCTs. No studies had been published in APS.The aim of the study is to investigate the efficacy and safety of rivaroxaban in preventing recurrent thrombosis in patients with APS compared with acenocoumarol
Detailed description
This is a phase 3 randomized, multicenter, non-inferiority open-label RCT. 190 eligible APS patients with arterial or venous thrombotic history receiving acenocoumarol will be stratified according the presence of SLE and venous/arterial thrombotic history and randomized (1:1) either to continue vitamin K antagonists (standard of care, normalized ratio (INR) 2-3 or 2.5 to 3.5 in those with recurrent thrombotic episodes) or to switch to rivaroxaban (20 mg/day). The primary efficacy outcome is the development of any thrombotic event during the study period. Secondary efficacy outcomes include time to thrombosis, type of thrombosis (arterial or venous), overall causes of death, evaluation of a prognostic biomarker panel of recurrent thrombosis. The primary safety outcome will be major bleeding. Secondary safety outcomes include any adverse event and minor bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rivaroxaban | Experimental | Drug: RivaroxabanRivaroxaban 20 mg per day |
| acenocumarol | Active comparator | Drug: acenocumarolINR adjusted dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with thrombotic antiphsopholipd syndrome
- Treated with acenocumarol for a minimum period of 6 months
- Positivity for Lupus anticoagulant and/or anti-cardiolipin or anti-B2GPI antibodies IgG or IgM≥40
Key exclusion criteria (10 listed)
- Major haemorrhage (cerebral or gastrointestinal) within the previous 6 months
- Neurosurgery within the previous 4 weeks
- Any surgery within the previous 10 days
- Active peptic ulcus
- ALT or GPT >120 UI/mL non-lupus related in the previous 30 days
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 |
|---|---|---|
| RivaroxabanAlso: XARELTORivaroxaban will be started at 20 mg/day. Dose will be adjusted according to Cr Clearance. Cr Clearance 30-49 ml/min will receive 15 mg/day. | Drug | rivaroxaban |
| acenocumarolAlso: SINTROMDoses will be adjusted according to INR | Drug | acenocumarol |
Primary outcome
Developement of a new thrombotic event (arterial or venous), confirmed by appropiate imaging studies
Time frame: 36 months
Stroke or transient ischemic attack, myocardial infarction, peripheral arterial thrombosis, cerebral vein thrombosis, deep-vein thrombosis, or pulmonary embolism) that was confirmed by adjudication
Incidence of major bleeding
Time frame: 36 months
Major bleeding is defined as clinically overt bleeding associated with any of the following: fatal bleeding causing death, involvement of a critical anatomic site (intracranial, spinal, intraocular, pericardial, articular, retroperitoneal, or intramuscular with compartment syndrome) or need for surgery or angiographic intervention to stop haemorrhage, fall in haemoglobin concentration of at least 20 g/L in 24 hours, and/or requiring non-planned transfusion of ≥2 units of packed red blood cells or whole blood
5 secondary outcomes
Incidence of any treatment-Emergent Adverse events
Time frame: 36 months
Death due to thrombotic events
Time frame: 36 months
Time to the first thrombotic event
Time frame: 36 months
Location of thrombotic events
Time frame: 36 months
Evaluation of a prognostic biomarker panel
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Josefina Cortes, MD,pHD principal investigator
Hospital Universitari Vall d'Hebron Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban and acenocumarol in people with Antiphospholipid Syndrome, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 10 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 11 May 2018. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Developement of a new thrombotic event (arterial or venous), confirmed by appropiate imaging studies (time frame: 36 months). The study lists 2 primary outcomes in all. 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 11 May 2018.