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SPARCL Trial - Stroke Prevention by Aggressive Reduction in Cholesterol Levels

Summary:

  • This was a prospective, randomized, multicenter, double-blind, placebo controlled clinical trial of 4,731 patients with recent stroke or TIA and without known CAD who were randomized to receive either atorvastatin 80 mg daily or placebo that showed atorvastatin use reduced the overall incidence of strokes and of cardiovascular events, despite a small increase in the incidence of hemorrhagic stroke.

SPARCL Trial Abstract

  • Amerenco P, et al. High-dose atorvastatin after stroke or transient ischemic stroke. N Engl J Med 2006;355(6):549-59. PubMed
    Study Design

    Prospective, Randomized, Multicenter, Double Blind, Placebo Controlled Trial

    Sample Size n = 4,731
    Patients

    Patients who had had a stroke or TIA within one to six months before study entry, had LDL-c levels of 100 to 190 mg per deciliter (2.6 to 4.9 mmol per liter), and had no known CHD.

    Groups Atorvastatin 80 mg daily or Placebo
    Follow Up Median of 4.9 years
    Results
    • During a median follow-up of 4.9 yrs, 265 patients (11.2 percent) receiving atorvastatin and 311 patients (13.1 percent) receiving placebo had a fatal or nonfatal stroke (5-year absolute reduction in risk, 2.2 percent; adjusted HR, 0.84; 95% Cl, 0.71 to 0.99; P=0.03; unadjusted P=0.05).
    • The atorvastatin group had 218 ischemic strokes and 55 hemorrhagic strokes, whereas the placebo group had 274 ischemic strokes and 33 hemorrhagic strokes.
    • The five-year ARR of major CV events was 3.5% (HR, 0.80; 95% CI, 0.69 to 0.92; P=0.002).
    • The overall mortality rate was similar, with 216 deaths in the atorvastatin group and 211 deaths in the placebo group (P=0.98), as were the rates of serious adverse events.
    Conclusion In patients with recent stroke or TIA and without known coronary heart disease, 80 mg of atorvastatin per day reduced the overall incidence of strokes and of cardiovascular events, despite a small increase in the incidence of hemorrhagic stroke.
    ClinicalTrials.gov NCT00147602