Status:
COMPLETED
ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial
Lead Sponsor:
UMC Utrecht
Conditions:
Brain Ischemia
Transient Ischemic Attack
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 alo...
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 p...
Eligibility Criteria
Inclusion
- 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
- (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
Key Trial Info
Start Date :
July 1 1997
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
4500 Patients enrolled
Trial Details
Trial ID
NCT00161070
Start Date
July 1 1997
End Date
December 1 2006
Last Update
March 22 2007
Active Locations (1)
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1
UMC Utrecht
Utrecht, Utrecht, Netherlands