Stroke Prevention by ORal Thrombin Inhibition V "SPORTIF V"

Completed

Phase N/A Results

Trial Description

To compare the safety and efficacy of an oral direct thrombin inhibitor (ximelagatran) with those of warfarin (coumadin) in preventing stroke and systemic embolic events in patients with atrial fibrillation.

Interventions

  • Warfarin (Coumadin┬«)Drug
    Intervention Desc: Anticoagulant (Vitamin K antagonist)
  • Ximelagatran (Exanta)Drug
    Intervention Desc: Oral anticoagulant. Prodrug is transformed into melagatran, an active site-directed thrombin inhibitor, after gastrointestinal absorption.

Trial Design

Randomized, open-label, parallel-group study, double blind, double-dummy treatment allocation and computerized algorithms to generate sham INR data.

Patient Involvement

Patients are randomized to receive either ximelagatran or warfarin. Warfarin is dosed to achieve an international normalized ratio (INR) of 2.0 - 3.0. Patients are treated for 12-28 months, during which time they have 15-18 follow-up visits. At each of these visits, blood tests, physical exams and electrocardiograms (EKG's) are performed. INRs will be monitored frequently.

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of stroke and systemic embolic events.
Secondary Stroke, death, TIA, myocardial infarction, major and minor bleeding.

Sponsors

AstraZeneca