Study Design

Study Design:

Patients Enrolled: 4,495
Mean Follow Up: Mean 3.6 ± 1 years
Mean Patient Age: Mean age 64.4 ± 7.6 years
Female: 58

Patient Populations:

One or more of the following major cardiovascular risk factors: old age (≥65 years), hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥95 mm Hg on at least three separate occasions), hypercholesterolemia (total blood cholesterol ≥6.4 mmol/l on at least two separate occasions), diabetes mellitus (fasting venous plasma glucose concentration ≥7.8 mmol/l on at least two separate occasions [chronic drug treatment for any of the three latter conditions was also a criterion for inclusion]), obesity (body mass index ≥30 kg/m²), and family history of MI before 55 years of age in at least one parent or sibling

Exclusions:

Treatment with antiplatelet drugs (history of vascular events or diseases), chronic use of anti-inflammatory agents or anticoagulants, contraindications to aspirin, diseases with predictable poor short-term prognosis, and predictable psychological or logistical difficulties affecting compliance with the trial requirements

Primary Endpoints:

The cumulative rate of cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal stroke

Secondary Endpoints:

Cardiovascular deaths, total deaths, and total cardiovascular events (cardiovascular death, nonfatal MI, nonfatal stroke, angina pectoris, transient ischemic attacks, peripheral artery disease, and revascularization procedures)

Drug/Procedures Used:

Using a 2x2 factorial design, eligible patients were randomized to receive aspirin (100 mg enteric coated aspirin per day) or no aspirin and vitamin E (300 mg synthetic α-tocopherol per day) or no vitamin E.