Rivaroxaban for Antiphospholipid Antibody Syndrome

NCT02116036 | Completed Phase 4

• 1 other identifier: G-13-0002011
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 6

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.

Conditions

Antiphospholipid Antibody Syndrome

Keywords

Antiphospholipid Antibody Syndrome; Rivaroxaban; Thromboembolism; Bleeding; Feasibility

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Bleeding

  Minimum of one year for all subjects

• Thrombosis

  Minimum of one year for all subjects

Study Arms (1)

Rivaroxaban

EXPERIMENTAL

Rivaroxaban 20mg po daily

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

Also known as: Xarelto

Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Heart and Stroke Foundation of Canada: collaborator
• Bayer: collaborator
• Hamilton Health Sciences Corporation: collaborator
• Jewish General Hospital: collaborator
• University of Alberta: collaborator
• The Ottawa Hospital: collaborator
• Queen Elizabeth II Health Sciences Centre: collaborator

Study Sites (6)

University of Alberta Hospital

Edmonton, Alberta, T6G 2P4, Canada

Location

Queen Elizabeth II Hospital

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

• 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.

  PMID: 32346486 DERIVED

MeSH Terms

Conditions

Antiphospholipid Syndrome; Thromboembolism; Hemorrhage

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: September 1, 2014
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

CA (6)