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Rivaroxaban for Antiphospholipid Antibody Syndrome (RAPS)

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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

Tracking Information
First Submitted Date  ICMJE April 14, 2014
First Posted Date  ICMJE April 16, 2014
Last Update Posted Date October 18, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
  • 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.
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2014)
  • Feasibility of identification for enrolment [ Time Frame: 18 months ]
    We define success as the ability to identify 150 eligible patients at 6 clinical centres over 18 months.
  • Feasibility of Consent [ Time Frame: 18 months ]
    We define success as a consent rate of 90% (thus, if we identify 150 patients, at least 135 will provide consent).
  • Compliance [ Time Frame: Minimum of one year for all subjects ]
    We define success as a patient missing fewer than 5% of days with pill administrations, as measured by pill counts.
Change History Complete list of historical versions of study NCT02116036 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2014)
  • Bleeding [ Time Frame: Minimum of one year for all subjects ]
    We 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.
  • Thrombosis [ Time Frame: Minimum of one year for all subjects ]
    We will collect and report the rates of objectively-confirmed venous and arterial thrombosis.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rivaroxaban for Antiphospholipid Antibody Syndrome
Official Title  ICMJE Rivaroxaban in Antiphospholipid Syndrome Pilot Study: A Multicenter Feasibility Study of Rivaroxaban for Patients With Antiphospholipid Syndrome and Prior Arterial or Venous Thrombosis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Antiphospholipid Antibody Syndrome
Intervention  ICMJE Drug: Rivaroxaban
Other Name: Xarelto
Study Arms  ICMJE Experimental: Rivaroxaban
Rivaroxaban 20mg po daily
Intervention: Drug: Rivaroxaban
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2017)
81
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2014)
150
Actual Study Completion Date  ICMJE September 30, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02116036
Other Study ID Numbers  ICMJE G-13-0002011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party St. Joseph's Healthcare Hamilton
Study Sponsor  ICMJE St. Joseph's Healthcare Hamilton
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account St. Joseph's Healthcare Hamilton
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP