Adouble-blind trial of aspirin for the treatment of cerebral ischemia was begun in 1972 and continued for 37 months. This was accomplished despite difficulties in controlling a long-term study of a drug which has widespread availability and consumption. The study design, criteria for selection of patients, follow-up surveillance, and methods of data analysis are presented. We report only subjects without carotid surgery before randomization. Patients (178) who had carotid transient ischemic attacks (TIAs) were randomly allocated to aspirin or placebo and followed to determine the incidence of subsequent TIAs,death, cerebral infarction or retinal infarction. Analysis of the first six months of follow-up revealed a statistically significant differential in favar of aspirin when death or cerebral or retinal infarction and the occurrence of TIAs were grouped and considered together as end points. Significance in favor of aspirin treatment was mainly revealed in patients with a history of multiple TIAs and was most evident in those individuals having carotid lesions appropriate to the TIA symptoms. It cannot be inferred from this study that aspirin prevents stroke because when end points were restriced to death or cerebral or retinal infarction, there was no statistically significant differential between the aspirin and placebo treatments.

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SUMMARY Patients (125) who had carotid transient ischemic attacks (TIAs) and one or more accessible carotid lesions visualized angiographically had reconstructive operations of the carotid artery and were then randomly assigned to aspirin or placebo treatment. They were followed to determine the incidence of subsequent TIAs, death, cerebral infarction, or retinal infarction.Life table analysis (for 24 months follow up) that eliminated deaths which were not stroke-related revealed a significant difference in favor of aspirin. Because of the small number of patients and the short period of follow up, these results should be interpreted only as consistent with those reported in the initial publication but not conclusive of an aspirin effect in preventing cerebral infarction.THE FOLLOWING report is the second to be published from the Aspirin in Transient Ischemic Attacks (AITIA) Study, a cooperative clinical trial designed to test the effectiveness of aspirin in vivo in the treatment of cerebral arterial thromboembolism and its consequences. The 2 main objectives of the AITIA study were to determine 1) whether oral administration of aspirin would result in the reduction or prevention of transient cerebral ischemic attacks (TIAs) of the hemispheric type and of transient monocular blindness or partial blindness (amaurosis fugax) and 2) whether oral administration of aspirin would result in a reduction of cerebral infarction and stroke-related mortality.In the initial publication, 1 details of the study design, criteria for selection of patients, follow up surveillance, and study results for nonsurgical patients were described. This report presents the results of a study of patients who had reconstructive operations of the carotid artery before being randomly allocated to either aspirin or placebo. Design and MethodsThe major design features of the AITIA trial are outlined below.1. Ten institutions throughout the United States plus a Central Registry-Drug Distribution Center* participated in the study.2. The drugs compared were aspirin and an indistinguishable placebo, administered at a daily fixed dose.3. Only subjects having episodes of monocular blindness or cerebral hemispheric type of TIA were eligible for admission to the study. Subjects