SOCRATES
Trial question
What is the effect of ticagrelor in patients with AIS or TIA?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 13199
13199 patients (5483 female, 7716 male)
Inclusion criteria: patients with nonsevere ischemic stroke or high-risk TIA who had not received intravenous or intraarterial thrombolysis and were not considered to have ha a cardioembolic stroke
Key exclusion criteria: specific antiplatelet therapy or anticoagulation therapy was planned or if carotid, cerebrovascular, or coronary revascularization was planned that would require halting study treatment within 7 days after randomization; hypersensitivity to ticagrelor or aspirin; history of AF, ventricular aneurysm, or suspicion of cardioembolic cause for TIA or stroke; underwent intravenous or intraarterial thrombolysis or mechanical thrombectomy within 24 hours before randomization
Interventions
N=6589 ticagrelor (180 mg loading dose on day 1 followed by 90 mg BID for days 2 through 90)
N=6610 aspirin (300 mg on day 1 followed by 100 mg daily for days 2 through 90)
Primary outcome
Time to occurrence of stroke, myocardial infarction, or death at 90 days
6.7
7.5
7.5 %
5.6 %
3.8 %
1.9 %
0.0 %
Ticagrelor
Aspirin
No significant
difference ↔
No significant difference in time to occurrence of stroke, myocardial infarction, or death at 90 days (6.7% vs. 7.5%; HR 0.89, 95% CI 0.78 to 1.01)
Secondary outcomes
Borderline significant decrease in ischemic stroke (5.8% vs. 6.7%; HR 0.87, 95% CI 0.76 to 1)
Safety outcomes
No significant differences in major bleeding (0.5% vs. 0.6%), ICH (0.2% vs. 0.3%), and fatal bleeding (0.1% vs. 0.1%).
Conclusion
In patients with nonsevere ischemic stroke or high-risk TIA who had not received intravenous or intraarterial thrombolysis and were not considered to have ha a cardioembolic stroke, ticagrelor was not superior to aspirin with respect to time to occurrence of stroke, myocardial infarction, or death at 90 days.
Reference
Johnston SC, Amarenco P, Albers GW et al. Ticagrelor versus Aspirin in Acute Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Jul 7;375(1):35-43.
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