Antiphospholipid Antibody SyndromePhase 4RAPSNCT02116036
Rivaroxaban for Antiphospholipid Antibody Syndrome
A Phase 4 study testing Rivaroxaban in people with Antiphospholipid Antibody Syndrome, run by St. Joseph's Healthcare Hamilton at 6 sites in Canada.
Trial summary
The antiphospholipid antibody syndrome (APS) is a syndrome associated with excessive blood clotting (thrombosis). APS is among the most common cause of heart attack and stroke in patients under the age of 50 and is particularly prevalent in patients with autoimmune conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiphospholipid Antibody Syndrome
- What is being tested?
- Rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 6 sitesCanada
- Study dates
- Sep 2014to 30 Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior objectively-confirmed venous thrombosis, irrespective of history of arterial thrombosis
- Two or more prior positive APS serological evaluations at least 12 weeks apart
- Current treatment with warfarin administered to achieve an INR of 2.0 to 3.0, rivaroxaban or dabigatran at any dose currently used for secondary prophylaxis of thrombosis, or short term therapeutic dose LMWH (for example, for the treatment of recently diagnosed deep vein thrombosis). Patients not currently receiving anticoagulation but in whom anticoagulation is mandated, may also be enrolled if a 20 mg rivaroxaban dose would be appropriate
Who cannot join
- Prior recurrent thrombosis while taking warfarin with a demonstrated INR of 2.0 to 3.0, or prior recurrent thrombosis while receiving dabigatran or rivaroxaban
- History of isolated arterial thrombosis (no history of venous thrombosis) pending CTA approval by Health Canada
- Need for continued treatment with both aspirin (irrespective of dose) AND clopidogrel
- Pregnancy or planned pregnancy during the study period; women who may become pregnant will be required to utilize reliable contraceptive measures while on study drug
- Chronic kidney disease with calculated GFR < 30mL/min
- Geographic inaccessibility
- Age < 18 years
- Inability or failure to provide informed consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2P4
Queen Elizabeth II Hospital
Halifax, Nova Scotia, B3H 2Y9
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Jewish General Hospital
Montreal, Quebec, H3T 1E2
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
About this study
Official title: Rivaroxaban in Antiphospholipid Syndrome Pilot Study: A Multicenter Feasibility Study of Rivaroxaban for Patients With Antiphospholipid Syndrome and Prior Arterial or Venous Thrombosis
The antiphospholipid antibody syndrome (APS) is a syndrome associated with excessive blood clotting (thrombosis). APS is among the most common cause of heart attack and stroke in patients under the age of 50 and is particularly prevalent in patients with autoimmune conditions. Patients with APS and prior thrombosis require lifelong anticoagulant therapy to prevent recurrent clots; such therapy is currently provided with warfarin. Warfarin requires frequent bloodwork monitoring, and many medications or foods can alter its effect, which can put people either at increased risk for clotting or bleeding. Rivaroxaban is a new mediation that prevents blood clots that does not require bloodwork monitoring and that has fewer interactions. This study is a pilot feasibility study which will: 1) examine our ability to identify 150 eligible APS patients; 2) measure our ability to obtain consent from 135 of these patients; and 3) test our hypothesis that we can obtain 95% compliance with daily rivaroxaban administration. The investigators propose to treat eligible patients with rivaroxaban 20 mg once daily. Patients will be followed for a minimum of one year and their rates of bleeding and thrombosis will be monitored as secondary outcome measures.
- Conditions
- Antiphospholipid Antibody Syndrome
- Being tested
- Rivaroxaban
- Keywords
- Antiphospholipid Antibody Syndrome, Rivaroxaban, Thromboembolism, Bleeding, Feasibility
- Medical subject headings
- Antiphospholipid Syndrome, Thromboembolism, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Xarelto
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Rivaroxaban 20mg po daily Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of identification for enrolment
The investigators define success as the ability to identify 150 eligible patients at 6 clinical centres over 18 months.
Measured: 18 months
Feasibility of Consent
The investigators define success as a consent rate of 90% (thus, if we identify 150 patients, at least 135 will provide consent).
Measured: 18 months
Compliance
The investigators define success as a patient missing fewer than 5% of days with pill administrations, as measured by pill counts.
Measured: Minimum of one year for all subjects
Secondary outcomes (2)
Bleeding
The investigators will collect and report the rates of minor bleeding (clinically apparent bleeding that does not meet the criteria for major), and major and fatal bleeding. Major bleeding will be defined by International Society of Thrombosis and Hemostasis criteria.
Measured: Minimum of one year for all subjects
Thrombosis
The investigators will collect and report the rates of objectively-confirmed venous and arterial thrombosis.
Measured: Minimum of one year for all subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startSep 2014
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antiphospholipid Antibody SyndromeStudies 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Bayer, Hamilton Health Sciences Corporation, Jewish General Hospital, University of Alberta, The Ottawa Hospital, Queen Elizabeth II Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Kimberly J Legault, MD, Principal investigator, St. Joseph's Healthcare Hamilton, Hamilton Health SciencesMark A Crowther, MD, MSc, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116036
- Sponsor's protocol ID
- G-13-0002011
- Acronym
- RAPS
- Status last verified
- Oct 2017
- First submitted
- 14 Apr 2014
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Legault K, Blostein M, Carrier M, Khan S, Schulman S, Shivakumar S, Wu C, Crowther MA. A single-arm feasibility cohort study of rivaroxaban in antiphospholipid syndrome. Pilot Feasibility Stud. 2020 Apr 25;6:52. doi: 10.1186/s40814-020-00594-1. eCollection 2020.
PubMed 32346486
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban in Antiphospholipid Syndrome Pilot Study: A Multicenter Feasibility Study of Rivaroxaban for Patients With Antiphospholipid Syndrome and Prior Arterial or Venous Thrombosis
- ClinicalTrials.gov ID
- NCT02116036
- Acronym / sponsor ID
- RAPS / G-13-0002011
- Conditions
- Antiphospholipid Antibody Syndrome
- Keywords
- Antiphospholipid Antibody Syndrome, Rivaroxaban, Thromboembolism, Bleeding, Feasibility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Bayer, Hamilton Health Sciences Corporation, Jewish General Hospital, University of Alberta, The Ottawa Hospital, Queen Elizabeth II Health Sciences Centre
- Study start
- Sep 2014
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 16 Apr 2014 (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 antiphospholipid antibody syndrome (APS) is a syndrome associated with excessive blood clotting (thrombosis). APS is among the most common cause of heart attack and stroke in patients under the age of 50 and is particularly prevalent in patients with autoimmune conditions. Patients with APS and prior thrombosis require lifelong anticoagulant therapy to prevent recurrent clots; such therapy is currently provided with warfarin. Warfarin requires frequent bloodwork monitoring, and many medications or foods can alter its effect, which can put people either at increased risk for clotting or bleeding. Rivaroxaban is a new mediation that prevents blood clots that does not require bloodwork monitoring and that has fewer interactions. This study is a pilot feasibility study which will: 1) examine our ability to identify 150 eligible APS patients; 2) measure our ability to obtain consent from 135 of these patients; and 3) test our hypothesis that we can obtain 95% compliance with daily rivaroxaban administration. The investigators propose to treat eligible patients with rivaroxaban 20 mg once daily. Patients will be followed for a minimum of one year and their rates of bleeding and thrombosis will be monitored as secondary outcome measures.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: RivaroxabanRivaroxaban 20mg po daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prior objectively-confirmed venous thrombosis, irrespective of history of arterial thrombosis
- Two or more prior positive APS serological evaluations at least 12 weeks apart
- Current treatment with warfarin administered to achieve an INR of 2.0 to 3.0, rivaroxaban or dabigatran at any dose currently used for secondary prophylaxis of thrombosis, or short term therapeutic dose LMWH (for example, for the treatment of recently diagnosed deep vein thrombosis). Patients not currently receiving anticoagulation but in whom anticoagulation is mandated, may also be enrolled if a 20 mg rivaroxaban dose would be appropriate
Key exclusion criteria (8 listed)
- Prior recurrent thrombosis while taking warfarin with a demonstrated INR of 2.0 to 3.0, or prior recurrent thrombosis while receiving dabigatran or rivaroxaban
- History of isolated arterial thrombosis (no history of venous thrombosis) pending CTA approval by Health Canada
- Need for continued treatment with both aspirin (irrespective of dose) AND clopidogrel
- Pregnancy or planned pregnancy during the study period; women who may become pregnant will be required to utilize reliable contraceptive measures while on study drug
- Chronic kidney disease with calculated GFR < 30mL/min
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: Xarelto | Drug | Rivaroxaban |
Primary outcome
Feasibility of identification for enrolment
Time frame: 18 months
The investigators define success as the ability to identify 150 eligible patients at 6 clinical centres over 18 months.
Feasibility of Consent
Time frame: 18 months
The investigators define success as a consent rate of 90% (thus, if we identify 150 patients, at least 135 will provide consent).
Compliance
Time frame: Minimum of one year for all subjects
The investigators define success as a patient missing fewer than 5% of days with pill administrations, as measured by pill counts.
2 secondary outcomes
Bleeding
Time frame: Minimum of one year for all subjects
Thrombosis
Time frame: Minimum of one year for all subjects
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 18 Oct 2017.
- Derived from this study: PubMed 32346486Legault K, Blostein M, Carrier M, Khan S, Schulman S, Shivakumar S, Wu C, Crowther MA. A single-arm feasibility cohort study of rivaroxaban in antiphospholipid syndrome. Pilot Feasibility Stud. 2020 Apr 25;6:52. doi: 10.1186/s40814-020-00594-1. eCollection 2020.
- 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.
Kimberly J Legault, MD principal investigator
St. Joseph's Healthcare Hamilton, Hamilton Health Sciences
Mark A Crowther, MD, MSc principal investigator
St. Joseph's Healthcare Hamilton
6 sites 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 in people with Antiphospholipid Antibody Syndrome, run by St. Joseph's Healthcare Hamilton at 6 sites in Canada.
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 8 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 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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 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?
Feasibility of identification for enrolment (time frame: 18 months). The study lists 3 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 NCT02116036, 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 18 Oct 2017.