RESULTS
STUDY PATIENTS AND FOLLOW-UP
Between October 2009 and July 2012, a total of
41,561 patients with stroke or TIA were screened at
114 clinical sites; 5170 patients were enrolled, with
2584 randomly assigned to the clopidogrel–aspirin
group and 2586 to the aspirin group. The most
common reasons for exclusion were delayed presentation
(26.4% of screened patients); moderate
or severe stroke (10.4%); intracranial hemorrhage
(7.0%); low-risk TIA, defined as a score of <4 on
the ABCD2 (6.5%); or contraindication to clopidogrel
or aspirin (6.0%) (Fig. S3 in the Supplementary
Appendix). The two groups were well balanced
regarding baseline characteristics (Table 1).
The median age was 62 years, and 33.8% of
the patients were women. A total of 65.7% of the
patients had a history of hypertension, 21.1%
had diabetes, and 43.0% were current or former
smokers. The median time from the onset of the
qualifying minor stroke or TIA to randomization
was 13 hours. The index event was a TIA in
1445 patients (27.9%). A total of 36 patients
(0.7%) — 20 in the clopidogrel–aspirin group
and 16 in the aspirin group — were lost to follow-
up; 165 patients (6.4%) in the clopidogrel–
aspirin group and 146 (5.6%) in the aspirin
group discontinued the study medication before
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