European / Australasian Stroke Prevention in Reversible Ischaemia Trial "ESPRIT"

Completed

Phase N/A Results

Trial Description

To compare the safety and prophylactic efficacies of mild anticoagulants, aspirin, in conjunction with dipyridamole, and aspirin alone against future vascular events in patients with atherosclerotic cerebral ischemia. ESPRIT will be divided into three sub-protocols: Scheme A will compare anticoagulants, aspirin combined with dipyridamole, and aspirin alone; Scheme B will compare aspirin in conjunction with dipyridamole with aspirin alone; Scheme C will compare aspirin with anticoagulants.

Interventions

Trial Design

International, multicenter, randomized, non-blinded, controlled trial with a three-arm treatment protocol.

Patient Involvement

Prior to randomization, all patients will undergo a medical history, neurological exam, hematological tests, chest X-ray, head CT, electrocardiography, and, if available, echocardiography and carotid duplex scanning. Eligible patients will be randomized to receive either oral anticoagulants dosed to yield an international normalized ratio (INR) of 2.0 - 3.0, aspirin 30 - 325 mg/day, or dipyridamole 400 mg/day combined with aspirin 30 - 325 mg/day. The preferred anticoagulant is phenprocoumon, but acenocoumarol and warfarin are also permitted. Patients receiving anticoagulants will have their INR evaluated every 3 months. All patients will attend a follow-up visit every 6 months for a period of 1-5 years, during which any occurrence of outcome events, bleeding complications, recurrent TIA's, or hospital admissions will be noted, use of trial medication will be evaluated, and Rankin Scale score will be determined. The final follow-up visit will also include a full neurological exam.

Outcomes

Type Measure Time Frame Safety Issue
Primary Combined incidence of vascular mortality, nonfatal stroke, nonfatal myocardial infarction, and major bleeding complications.
Secondary Mortality rate, all stroke, vascular interventions, lower-extremity amputations, retinal infarction or hemorrhage.

Sponsors

Netherlands Heart Foundation and the UK Stroke Association.