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NCT Number: NCT02116036

Rivaroxaban for Antiphospholipid Antibody Syndrome

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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Key information

Conditions

Antiphospholipid Antibody Syndrome Antiphospholipid Syndrome Autoimmune Diseases Cardiovascular Diseases Embolism and Thrombosis Hemorrhage Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban

Drug

Other names: Xarelto

Primary outcomes

  1. Feasibility of identification for enrolment

    Time frame: 18 months

    The investigators define success as the ability to identify 150 eligible patients at 6 clinical centres over 18 months.

  2. Feasibility of Consent

    Time frame: 18 months

    The investigators define success as a consent rate of 90% (thus, if we identify 150 patients, at least 135 will provide consent).

  3. Compliance

    Time frame: 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 outcomes

  1. Bleeding

    Time frame: 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.

  2. Thrombosis

    Time frame: Minimum of one year for all subjects

    The investigators will collect and report the rates of objectively-confirmed venous and arterial thrombosis.

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • Bayer
  • Hamilton Health Sciences Corporation
  • Heart and Stroke Foundation of Canada
  • Jewish General Hospital
  • Queen Elizabeth II Health Sciences Centre
  • The Ottawa Hospital
  • University of Alberta

Registry information

Official study title

Rivaroxaban in Antiphospholipid Syndrome Pilot Study: A Multicenter Feasibility Study of Rivaroxaban for Patients With Antiphospholipid Syndrome and Prior Arterial or Venous Thrombosis

Acronym: RAPS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 16, 2014
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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