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Rivaroxaban for Antiphospholipid Antibody Syndrome

NCT02116036 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2017-10-18

No results posted yet for this study

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.

Conditions

  • Antiphospholipid Antibody Syndrome

Interventions

DRUG

Rivaroxaban

Sponsors & Collaborators

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • Jewish General Hospital

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • The Ottawa Hospital

    collaborator OTHER

  • Queen Elizabeth II Health Sciences Centre

    collaborator OTHER

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Kimberly J Legault, MD · St. Joseph's Healthcare Hamilton, Hamilton Health Sciences

  • Mark A Crowther, MD, MSc · St. Joseph's Healthcare Hamilton

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116036 on ClinicalTrials.gov