Clinical Trial: Rivaroxaban for Antiphospholipid Antibody Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Rivaroxaban in Antiphospholipid Syndrome Pilot Study: A Multicenter Feasibility Study of Rivaroxaban for Patients With Antiphospholipid Syndrome

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 Summary:
Sponsor: St. Joseph's Healthcare Hamilton

Current Primary Outcome:

• 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:

• 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.

Current Secondary Outcome:

• 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:

• 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.

Information By: St. Joseph's Healthcare Hamilton

Dates:
Date Received: April 14, 2014
Date Started: September 2014
Date Completion: December 2016
Last Updated: July 23, 2015
Last Verified: July 2015