ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

UMC Utrecht4,500 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

4,500

Conditions

Brain Ischemia Transient Ischemic Attack Arteriosclerosis

Interventions

anticoagulationDRUG

aspirin and dipyridamoleDRUG

aspirin aloneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

UMC Utrecht

Utrecht, Utrecht, Netherlands

Outcomes

Primary Outcomes

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 Outcomes

Death from all causes

death from vascular causes

death from vascular causes or nonfatal stroke

fatal or nonfatal stroke

death from vascular causes, nonfatal stroke, nonfatal myocardial infarction or vascular intervention

major bleeding complications

amputations of lower extremities

retinal infarction or bleeding

Data from ClinicalTrials.gov

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