Low-dose acetylsalicylic acid (ASA) plus dipyridamole versus dipyridamole alone in stroke prevention

Completed

Phase N/A Results

Trial Description

To determine whether dipyridamole or aspirin + dipyridamole would produce significant reduction in the subsequent occurrence of reversible ischemic attacks and completed stroke.

Interventions

Trial Design

Non-randomized clinical trial of 244 patients.

Patient Involvement

Patients with a known history of peptic ulcer, active ulcer, hiatal hernia, intolerance to ASA or non-specific dyspepsia were assigned to receive dipyridamole alone (400 mg/day in two 50 mg capsules given 4 times daily). All other patients were assigned to receive dipyridamole (300 mg/day in two 50 mg capsules given 3 times daily) and ASA (100 mg/48 h). Patients received follow-up visits every 3 months for an average of 21 months. Patients were withdrawn if they were lost to follow-up, failed to take the study medication for 1 month, started taking other platelet aggregation inhibiting drugs, underwent surgery, or suffered mitral valve prolapse or paroxysmal atrial fibrillation.

Outcomes

Type Measure Time Frame Safety Issue
Primary Complete stroke, death, transient ischemic attack (TIA), reversible ischemic neurologic deficit (RIND), reversible ischemic neurologic deficit with incomplete resolution (RIND-IR).