Authors
Kennedy J, Hill MD, Ryckborst KJ, et al.
Title
Fast assessment of stroke and transient ischemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial
References
Lancet Neurol 2007;6:961-969.
Background
The optimum antiplatelet treatment for patients with TIA or minor stroke is unknown.
Purpose
To determine whether clopidogrel and simvastatin, if started early (within 24 hours of symptom onset) reduces the risk of stroke after TIA or minor stroke.
Design
  • Multicenter,randomised,2x2 factorial design, double-blinded, controlled pilot trial
  • 396 patients, age ≥ 40 years with a minor stroke (NIHSS score ≤3) or TIA within 24 hours of onset.
Exclusion Criteria
None.
Follow-Up
90 days
Treatment Regimen
  • Clopidogrel (300 mg loading dose followed by 75 mg daily) or matching placebo
  • Simvastatin 40 mg daily or matching placebo
  • All patients received aspirin 162 mg load (if aspirin naïve), then 81 mg daily

Treatment duration: 90 days
Results
Due to increased use of statins (exclusion criteria for enrolment), the trial failed to meet its enrolment target of 500 patients, therefore the trial was closed early.

Primary Endpoint: Any stroke (ischemic or haemorrhagic) within 90 days of randomisation.

Stroke within 90 days occurred in 7.1% of patients on clopidogrel and 10.8% of patients on placebo. (risk ratio 0.7; CI: 0.3-1.2;ARR -3.8% (CI:-9.4-1.9); p=0.19).

Stroke within 90 days occurred in 10.6% of patients on simvastatin and 7.3% of patients on placebo (risk ratio 1.3; CI 0.7-2.4; absolute risk increase 3.3% (-2.3-8.9); p=0.25).

Two patients on clopidogrel had intracranial hemorrhage, while none occurred in patients on placebo (absolute risk increase 1% (-0.4-2.4;p=0.5).
Summary
Due to increased use of statins (exclusion criteria for enrolment), the trial failed to meet its enrolment target of 500 patients, therefore the trial was closed early. No definite conclusions can be made.
Implications
None.
Related Figures
[7]