ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

Sponsor

UMC Utrecht (Other)

Overall Status

Completed

CT.gov ID

NCT00161070

Collaborator

(none)

4,500

Enrollment

Location

113

Duration (Months)

39.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Ischemia Transient Ischemic Attack Arteriosclerosis	Drug: anticoagulation Drug: aspirin and dipyridamole Drug: aspirin alone	Phase 4

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:

oral AC (INR 2.0 to 3.0);
the combination of DIP (400 mg daily) plus ASA (30-325 mg/day); or
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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

Study Start Date :

Jul 1, 1997

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

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

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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