Acronym: Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke
Purpose: Comparison of aspirin plus clopidogrel vs. aspirin alone for reduction of recurrent stroke in patients with transient ischemic attack or minor ischemic stroke
Format: Randomized, double-blind, placebo-controlled
Treatment Group: Aspirin (50 to 325 mg/day) plus clopidogrel (loading dose of 600 mg on day 1 followed by 75 mg per day)
Control group: Aspirin alone
Number of Participants: 4,881
Inclusion Criteria: Minor ischemic stroke or high-risk transient ischemic attack
Primary Outcome(s): Risk for a composite of major ischemic events, defined as ischemic stroke, myocardial infarction or death from an ischemic vascular event at 90 days
Follow-up: 90 days
Summary: The study was halted after 84% enrollment due to determination that the combination therapy was linked to lower risk for major ischemic events and higher risk for major hemorrhage at 90 days compared with aspirin. Major ischemic events occurred in 5% of patients assigned clopidogrel plus aspirin and in 6.5% of patients assigned aspirin plus placebo (HR = 0.75; 95% CI, 0.59-0.95). In the cohort receiving clopidogrel plus aspirin, 0.9% of patients experienced major hemorrhage vs. 0.4% in the cohort that received aspirin plus placebo (HR = 2.32; 95% CI, 1.1-4.87).
Johnston SC, et al. N Engl J Med. 2018;doi:10.1056/NEJMoa1800410.
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