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

Centers: 269

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).

Original Publication:

Johnston SC, et al. N Engl J Med. 2018;doi:10.1056/NEJMoa1800410.

Link to Cardiology Today Article: