Lipitor In The Prevention Of Stroke, For Patients Who Have Had A Previous Stroke "SPARCL"

Completed

Phase 4 Results

Trial Description

To determine whether Lipitor reduces stroke, compared to placebo in patients who have had a previous stroke or transient ischemic attack.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Eligible patients were randomized to receive either atorvastatin 80 mg/day or placebo. Patients in both groups will be assessed at 1, 3, and 6 months, and every 6 months thereafter for 5 years.

Outcomes

Type Measure Time Frame Safety Issue
Primary First nonfatal or fatal stroke.
Secondary Stroke or TIA, major coronary event (death from cardiac causes, nonfatal myocardial infarction, or resuscitation after cardiac arrest), major cardiovascular event (stroke plus any major coronary event), acute coronary event (major coronary event or unstable angina), any coronary event (acute coronary event plus a coronary revascularization procedure, unstable angina, or angina or ischemia requiring emergency hospitalization), revascularization procedure (coronary, carotid, or peripheral), and any cardiovascular event (any of the former plus clinically significant peripheral vascular disease), individual components of the composite end points and death from any cause.
Primary Time to occurrence of fatal or non-fatal stroke
Secondary Time to occurrence of an acute coronary event, consisting of cardiac death, nonfatal myocardial infarction, resuscitated cardiac arrest or unstable angina.
Secondary Time to occurrence of a cerebrovascular event, defined as fatal or nonfatal stroke or TIA.

Sponsors