Rivaroxaban for Antiphospholipid Antibody Syndrome

Launched by ST. JOSEPH'S HEALTHCARE HAMILTON · Apr 14, 2014

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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