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ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00161070
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 22, 2007
Information provided by:
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.

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:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 4500 participants
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 : July 1997
Actual Study Completion Date : December 2006

Primary Outcome Measures :
  1. 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 :
  1. Death from all causes
  2. death from vascular causes
  3. death from vascular causes or nonfatal stroke
  4. fatal or nonfatal stroke
  5. death from vascular causes, nonfatal stroke, nonfatal myocardial infarction or vascular intervention
  6. major bleeding complications
  7. amputations of lower extremities
  8. retinal infarction or bleeding

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00161070

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UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
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Principal Investigator: A. Algra, Professor UMC Utrecht
Principal Investigator: J. Gijn Van, Professor UMC Utrecht
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00161070    
Other Study ID Numbers: 96-217
Heart Found.: 97.026
Eur. Com.: QLK6-CT-2002-02332
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 22, 2007
Last Verified: March 2007
Keywords provided by UMC Utrecht:
secondary prevention
TIA / minor stroke
atherosclerotic origin
TIA (Transient Ischemic Attack)
prevention & control
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Phosphodiesterase Inhibitors