| Authors |
| SPARCL Investigators |
| Title |
| High-Dose Atorvastatin after Stroke or Transient Ischemic Attack |
| References |
| N Engl J Med. 2006 Aug 10;355(6):549-59. |
| Background |
| Statins reduce the incidence of strokes among patients at increased risk for cardiovascular disease; whether they reduce the risk of stroke after a recent stroke or transient ischemic attack (TIA) remains to be established. |
| Purpose |
| To determine whether a daily dose of 80 mg of atorvastatin would reduce the risk of stroke in patients with no known coronary heart disease who had had a stroke or TIA within the previous six months. |
| Design |
- Randomized, double-blind, placebo-controlled trial
- 4731 patients with stroke or TIE within 1-6 months before study entry
- LDL 2.6-4.9 mmol/L
- No known coronary artery disease
|
| Exclusion Criteria |
- Atrial fibrillation
- Other cardiac sources of embolism
- Subarachnoid hemorrhage
|
| Follow-Up |
| Median 4.9 years |
| Treatment Regimen |
- Atorvastatin 80mg/day or placebo
- Follow up at 1, 3, 6 months after enrolment and then every 6 months thereafter with clinical and lab assessments
|
| Results |
Primary Endpoints Atorvastatin
n=2365 | Placebo
n=2366 | Hazard Ratio | p |
|---|
| Fatal or non-fatal stroke |
|---|
| 11.2% | 13.1% | 0.84 (0.71-0.99) | 0.03 | | Non-fatal stroke |
|---|
| 10.4% | 11.8% | 0.87 (0.73-1.03) | 0.11 | | Fatal stroke |
|---|
| 1.0% | 1.7% | 0.57 (0.35-0.95) | 0.03 | Secondary Outcomes (please refer to study for other results) - Stroke or TIA atorvastatin reduced by 23%; p<0.001
- Combined CV-death and non-fatal MI atorvastatin reduced by 35%; p=0.003
- Major cardiovascular event atorvastatin reduced by 20%; p=0.002
- No reduction in total death, CV death or non-CV death
|
| Summary |
| 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. |