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
|Condition or disease||Intervention/treatment||Phase|
|Antiphospholipid Antibody Syndrome||Drug: Rivaroxaban||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Rivaroxaban 20mg po daily
Other Name: Xarelto
- 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.
- 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.
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
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2P4|
|Canada, Nova Scotia|
|Queen Elizabeth II Hospital|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|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|
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|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|