SPARCL
Trial question
What is the role of atorvastatin in patients with recent stroke or TIA and without known coronary artery disease?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 4731
4731 patients (1908 female, 2823 male).
Inclusion criteria: patients with recent stroke or TIA within one to six months, had LDL-C levels of 100-190 mg/dL and without known coronary artery disease.
Key exclusion criteria: AF, other cardiac sources of embolism, and subarachnoid hemorrhage.
Interventions
N=2365 atorvastatin (80 mg/day).
N=2366 placebo (matching placebo every day).
Primary outcome
Fatal or nonfatal stroke
11.2%
13.1%
13.1 %
9.8 %
6.5 %
3.3 %
0.0 %
Atorvastatin
Placebo
Significant
decrease ▼
NNT = 52
Significant decrease in fatal or nonfatal stroke (11.2% vs. 13.1%; HR 0.84, 95% CI 0.71 to 0.99).
Secondary outcomes
Significant decrease in major CV events (14.1% vs. 17.2%; HR 0.8, 95% CI 0.69 to 0.92).
No significant difference in death from any cause (9.1% vs. 8.9%; HR 1, 95% CI 0.82 to 1.21).
Significant decrease in strokes or TIA (15.9% vs. 20.1%; HR 0.77, 95% CI 0.67 to 0.88).
Safety outcomes
No significant difference in serious adverse events.
Significant differences in liver enzymes elevation (2.2% vs. 0.5, p < 0.001).
Conclusion
In patients with recent stroke or TIA within one to six months, had LDL-C levels of 100-190 mg/dL and without known coronary artery disease, atorvastatin was superior to placebo with respect to fatal or nonfatal stroke.
Reference
Amarenco P, Bogousslavsky J, Callahan A rd et al. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006 Aug 10;355(6):549-59.
Open reference URL