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Rivaroxaban for Antiphospholipid Antibody Syndrome (RAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02116036
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : October 18, 2017
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Bayer
Hamilton Health Sciences Corporation
Jewish General Hospital
University of Alberta
The Ottawa Hospital
Queen Elizabeth II Health Sciences Centre
Information provided by (Responsible Party):
St. Joseph's Healthcare Hamilton

Study Description
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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.

Condition or disease Intervention/treatment Phase
Antiphospholipid Antibody Syndrome Drug: Rivaroxaban Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Start Date : September 2014
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
Drug Information available for: Rivaroxaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rivaroxaban
Rivaroxaban 20mg po daily
 Drug: Rivaroxaban
Other Name: Xarelto


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116036


Locations
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Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2P4
Canada, Nova Scotia
Queen Elizabeth II Hospital
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Heart and Stroke Foundation of Canada
Bayer
Hamilton Health Sciences Corporation
Jewish General Hospital
University of Alberta
The Ottawa Hospital
Queen Elizabeth II Health Sciences Centre
Investigators
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Principal Investigator: Kimberly J Legault, MD St. Joseph's Healthcare Hamilton, Hamilton Health Sciences
Principal Investigator: Mark A Crowther, MD, MSc St. Joseph's Healthcare Hamilton
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT02116036    
Other Study ID Numbers: G-13-0002011
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by St. Joseph's Healthcare Hamilton:
Antiphospholipid Antibody Syndrome
Rivaroxaban
Thromboembolism
Bleeding
Feasibility
Additional relevant MeSH terms:
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Antiphospholipid Syndrome
Syndrome
Disease
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Rivaroxaban
 Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants