Clinical trial NCT02116036: Rivaroxaban for Antiphospholipid Antibody Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antiphospholipid Antibody Syndrome
Keywords: Antiphospholipid Antibody Syndrome
Rivaroxaban
Thromboembolism
Bleeding
Feasibility
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: Bayer
name: Hamilton Health Sciences Corporation
name: Jewish General Hospital
name: University of Alberta
name: The Ottawa Hospital
name: Queen Elizabeth II Health Sciences Centre
First posted: 2014-04-16
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Feasibility of identification for enrolment
timeFrame: 18 months
measure: Feasibility of Consent
timeFrame: 18 months
measure: Compliance
timeFrame: Minimum of one year for all subjects
Secondary outcomes:
measure: Bleeding
timeFrame: Minimum of one year for all subjects
measure: Thrombosis
timeFrame: Minimum of one year for all subjects
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II Hospital
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: St. Joseph's Healthcare Hamilton, Hamilton Health Sciences
name: Kimberly J Legault, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Healthcare Hamilton
name: Mark A Crowther, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.