Danish very-low-dose aspirin after carotid endarterectomy trial

Completed

Phase N/A Results

Trial Description

To evaluate the effect of very-low-dose aspirin as an antithrombotic agent in patients who had recently undergone carotid endarterectomy.

Interventions

Trial Design

Randomized, double-blind trial of 301 patients at 2 centers.

Patient Involvement

Patients were randomized to receive 50 mg of aspirin initially or placebo. If platelet inhibition was <80% compared to baseline after 2 months, it was measured again 1 week later and the aspirin dose was increased in 10-mg increments until satisfactory inhibition had been obtained. Some patients in the placebo group also had their doses adjusted at random with placebo tablets. Interviews and neurologic examinations were performed before and after surgery, 2 months after entry and every 6 months thereafter for an average of about 2 years.

Outcomes

Type Measure Time Frame Safety Issue
Primary Platelet aggregation, amaurosis fugax, retinal infarction, transient ischemic attack, stroke, acute myocardial infarction, nonvascular death, vascular death.

Sponsors

Danish Heart Foundation, Danish Insurance Association, Leo Pharmaceutical Products