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Sponsored by: |
UMC Utrecht |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00161070 |
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 | Intervention | Phase |
---|---|---|
Brain Ischemia Transient Ischemic Attack Arteriosclerosis |
Drug: anticoagulation Drug: aspirin and dipyridamole Drug: aspirin alone |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial |
Estimated Enrollment: | 4500 |
Study Start Date: | July 1997 |
Study Completion Date: | December 2006 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 96-217, Heart Found.: 97.026, Eur. Com.: QLK6-CT-2002-02332 |
Study First Received: | September 8, 2005 |
Last Updated: | March 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00161070 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
secondary prevention TIA / minor stroke atherosclerotic origin TIA (Transient Ischemic Attack) prevention & control |
Arterial Occlusive Diseases Ischemic Attack, Transient Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Arteriosclerosis |
Ischemia Brain Diseases Cerebrovascular Disorders Aspirin Neoplasm Metastasis Brain Ischemia Dipyridamole |
Anti-Inflammatory Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Hematologic Agents Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Fibrin Modulating Agents |
Phosphodiesterase Inhibitors Pathologic Processes Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Platelet Aggregation Inhibitors Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |