RESTART
Trial question
What is the effect of antiplatelet therapy on recurrent intracerebral hemorrhage?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 537
537 patients (177 female, 360 male).
Inclusion criteria: patients on antithrombotic therapy who survived 24h post ICH after discontinuation of antithrombotic therapy.
Key exclusion criteria: pregnancy, lactation, or childbearing age with no current contraception; traumatic intracerebral hemorrhage; hemorrhagic transformation of an ischemic cerebrovascular accident or ICH without intracerebral extension; taking antithrombotic therapy after intracerebral hemorrhage.
Interventions
N=268 restarting antiplatelets (aspirin, dipyridamole, or clopidogrel).
N=268 avoiding antiplatelets (no antiplatelet therapy).
Primary outcome
Rate of recurrence of ICH at a median of 2 years
4%
9%
9.0 %
6.8 %
4.5 %
2.3 %
0.0 %
Restarting
antiplatelets
Avoiding
antiplatelets
No significant
difference ↔
No significant difference in the rate of recurrence of ICH at a median of 2 years (4% vs. 9%; HR 0.51, 95% CI 0.25 to 1.03).
Secondary outcomes
No significant difference in major hemorrhagic events (7% vs. 9%; HR 0.71, 95% CI 0.39 to 1.3).
No significant difference in major occlusive vascular events (15% vs. 14%; HR 1.02, 95% CI 0.65 to 1.6).
Safety outcomes
No significant difference in few serious adverse events (n=11) unrelated to stroke.
Conclusion
In patients on antithrombotic therapy who survived 24h post ICH after discontinuation of antithrombotic therapy, restarting antiplatelets were not superior to avoiding antiplatelets with respect to the rate of recurrence of ICH at a median of 2 years.
Reference
RESTART Collaboration. Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial. Lancet. 2019 Jun 29;393(10191):2613-2623.
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