Rivaroxaban for Antiphospholipid Antibody Syndrome

Phase 4

Completed

• Conditions: Antiphospholipid Antibody Syndrome
• Interventions: Drug: Rivaroxaban

• Registration Number: NCT02116036
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-14
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-16
• Study Start: 2014-09
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban	Rivaroxaban 20mg po daily

Primary Outcome Measures

Name	Time	Method
Feasibility of identification for enrolment	18 months	The investigators define success as the ability to identify 150 eligible patients at 6 clinical centres over 18 months.
Feasibility of Consent	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	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.

Secondary Outcome Measures

Name	Time	Method
Thrombosis	Minimum of one year for all subjects	The investigators will collect and report the rates of objectively-confirmed venous and arterial thrombosis.
Bleeding	Minimum of one year for all subjects	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.

Trial Locations

Locations (6)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Queen Elizabeth II Hospital; 🇨🇦 Halifax, Nova Scotia, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada