Persantine-aspirin reinfarction study. Design, methods and baseline results. By the persantine-aspirin reinfarction...

The Persantine-Aspirin Reinfarction Study (PARIS) was a randomized, controlled, double-blind study of dipyridamole (Persantine) and aspirin in secondary prevention of coronary heart disease. Two thousand twenty-six men and women with myocardial infarction (MI) documented by electrocardiographic findings, clinical history and cardiac enzymes were followed for a minimum of 3 years and monitored for mortality (total and cause-specific), recurrent MI and other cardiovascular events. The study had a unique structure that provides a model for large-scale industry-sponsored clinical trials. Although financed by a private pharmaceutical firm, the study was completely independent of the funding sponsor. Sixteen American and four British clinics participated in the study, along with a Coordinating Center, and ECG Reading Center, a Central Laboratory, and a Drug Distribution Center. In addition, the study included an independent Data Quality Control Center that monitored the performance of the Coordinating Center. The rationale, organization, design and baseline results are presented in this report.