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Maasland L et al. – Data confirm that pts with ischemic attack and stroke in randomized clinical trials are only partially representative of pts in clinical practice. Use of less strict enrollment criteria may enhance "generalizability" and result in more efficient selection of pts for randomized clinical trials.
Methods- Estimate of the eligibility for participation in landmark trials of antiplatelet drugs of an unselected group of pts with stroke or transient ischemic attack from a national stroke survey
- Prospective study of 972 pts transient ischemic attack or ischemic stroke from Netherlands Stroke Survey
- Application of 7 large antiplatelet trials' enrollment criteria
- In total, 886 pts discharged alive and available for secondary prevention
- Mean follow-up: 2.5 yrs
- Annual rate of transient ischemic attack, stroke, or nonfatal myocardial infarction: 6.7%
- Proportion of pts fulfilling trial enrollment criteria: 25%-67%
- Mortality significantly higher in ineligible pts (27%-41%) than in pts fulfilling enrollment criteria (16%-20%)
- Rates of vascular events not higher in trial-eligible pts than in ineligible pts
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