ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

This study has been completed.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00161070
First received: September 8, 2005
Last updated: March 21, 2007
Last verified: March 2007
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

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

Estimated Enrollment: 4500
Study Start Date: July 1997
Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161070

Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: A. Algra, Professor UMC Utrecht
Principal Investigator: J. Gijn Van, Professor UMC Utrecht
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00161070     History of Changes
Other 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
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
secondary prevention
TIA / minor stroke
atherosclerotic origin
TIA (Transient Ischemic Attack)
prevention & control

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Brain Ischemia
Brain Diseases
Ischemic Attack, Transient
Ischemia
Stroke
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Aspirin
Dipyridamole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 26, 2014