Fast Assessment of Stroke and Transient ischemic attack to prevent Early Recurrence - Pilot Study "FASTER "

Completed

Phase N/A Results

Trial Description

This pilot phase will determine the feasibility of enrolment of patients to a stroke prevention trial within 24 hours of symptom onset and to assess the occurrence of adverse events and laboratory safety of early treatment initiation.

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Simvastatin Drug
    Intervention Desc: HMG-CoA reductase inhibitor; lowers cholesterol

Trial Design

Multi-center, randomized, double-blind, controlled trial, 2x2 factorial design.

Patient Involvement

All patients will be on aspirin. Patients will be randomized to clopidogrel (300mg loading dose + 75mg/day) or placebo and to simvastatin (40mg/day) or placebo within 24 hours of onset of TIA or minor stroke.

Outcomes

Type Measure Time Frame Safety Issue
Primary Any stroke at 90 days, stroke severity.
Secondary Composite of stroke, myocardial infarction, or vascular death at 90 days.

Sponsors

Canadian Stroke Consortium, Canadian Stroke Network, Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Ministry of Health and Long-Term Care Ontario, Merck Research Laboratories.