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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Canada | OTHER |
| Bayer | INDUSTRY |
| Hamilton Health Sciences Corporation | OTHER |
| Jewish General Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Experimental | Rivaroxaban 20mg po daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of identification for enrolment | The investigators define success as the ability to identify 150 eligible patients at 6 clinical centres over 18 months. | 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). | 18 months |
| Compliance | The investigators define success as a patient missing fewer than 5% of days with pill administrations, as measured by pill counts. | Minimum of one year for all subjects |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Minimum of one year for all subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly J Legault, MD | St. Joseph's Healthcare Hamilton, Hamilton Health Sciences | Principal Investigator |
| Mark A Crowther, MD, MSc | St. Joseph's Healthcare Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2P4 | Canada | ||
| Queen Elizabeth II Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32346486 | Derived | 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. |
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| ID | Term |
|---|---|
| D016736 | Antiphospholipid Syndrome |
| D013923 | Thromboembolism |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| OTHER |
| University of Alberta | OTHER |
| The Ottawa Hospital | OTHER |
| Queen Elizabeth II Health Sciences Centre | OTHER |
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| Thrombosis |
The investigators will collect and report the rates of objectively-confirmed venous and arterial thrombosis. |
| Minimum of one year for all subjects |
| Halifax |
| Nova Scotia |
| B3H 2Y9 |
| Canada |
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| D002318 |
| Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |