ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

Phase 4

Completed

• Conditions: Brain Ischemia; Transient Ischemic Attack; Arteriosclerosis

• Registration Number: NCT00161070
• Lead Sponsor: UMC Utrecht

Brief Summary

The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment with aspirin alone after cerebral ischemia of arterial origin.

Detailed Description

Low-dose aspirin (ASA) (at least 30 mg/day) prevents only 13% of subsequent vascular events after minor cerebral ischemia of arterial origin. Anticoagulation (AC) has been proven highly effective in preventing vascular events after myocardial infarction and after cerebral ischemia in patients with atrial fibrillation. A previous study on the effects of AC after cerebral ischemia of arterial origin (SPIRIT) showed that high intensity AC (INR 3.0 to 4.5) is not safe, but that mild AC (INR 2.0 to 3.0) was. The 2nd European Stroke Prevention Trial (ESPS-2) reported a 22% relative risk reduction of the combination of ASA and dipyridamole (DIP) above that of ASA only; its results, however, are subject to debate.

Study design: ESPRIT was an open randomised controlled trial allocating patients who experienced a transient ischemic attack (TIA) or a non-disabling ischemic stroke to either:

A. oral AC (INR 2.0 to 3.0);

B. the combination of DIP (400 mg daily) plus ASA (30-325 mg/day); or

C. ASA only (same dose).

The mean follow-up was three years. Primary outcome was the composite of vascular death, stroke, myocardial infarction or major bleeding. Outcome assessment is blind.

Study Timeline

• Study Start: 1997-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Completion: 2006-12
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-21
• Last Update Posted: 2007-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4500

Inclusion Criteria

• Patients presenting in the participating hospitals with a TIA or non-disabling stroke of atherosclerotic origin
• Randomisation within 6 months after the TIA or minor stroke
• Modified Rankin scale of 3 or less

Exclusion Criteria

• (Contra)indication to, or intolerance to, anticoagulants, dipyridamole, or aspirin
• Disease expected to cause death within weeks or months
• Source of embolism in the heart
• Moderate or severe ischemic damage to the white matter of the brain (leukoaraiosis)
• Anemia, polycythemia, thrombocytosis, or thrombocytopenia
• Planned carotid endarterectomy
• Intracranial bleeding or cerebral tumour
• TIA or stroke caused by vasculitis, migraine, or dissection
• Severe hypertension
• Liver failure
• Pregnancy
• Chronic alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The combined event of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happens first during follow-up

Secondary Outcome Measures

Name	Time	Method
major bleeding complications
Death from all causes
death from vascular causes
death from vascular causes or nonfatal stroke
fatal or nonfatal stroke
retinal infarction or bleeding
death from vascular causes, nonfatal stroke, nonfatal myocardial infarction or vascular intervention
amputations of lower extremities

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands