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European/Australasian Stroke Prevention in Reversible Ischaemia Trial
ISRCTN ISRCTN73824458
DOI 10.1186/ISRCTN73824458
ClinicalTrials.gov identifier NCT00161070
EudraCT number
Public title European/Australasian Stroke Prevention in Reversible Ischaemia Trial
Scientific title
Acronym ESPRIT
Serial number at source N/A
Study hypothesis Results of trials of aspirin and dipyridamole combined versus aspirin alone for the secondary prevention of vascular events after ischaemic stroke of presumed arterial origin are inconsistent. The aim of the study is to resolve this uncertainty.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Ischaemia
Participants - inclusion criteria 1. Patients presenting in the participating hospitals with a transient ischaemic attack (TIA) or non-disabling stroke of atherosclerotic origin
2. Randomisation within 6 months after the TIA or minor stroke
3. Modified Rankin scale of 3 or less
Participants - exclusion criteria 1. (Contra)indication to, or intolerance to, anticoagulants, dipyridamole, or aspirin
2. Disease expected to cause death within weeks or months
3. Source of embolism in the heart
4. Moderate or severe ischemic damage to the white matter of the brain (leukoaraiosis)
5. Anemia, polycythemia, thrombocytosis, or thrombocytopenia
6. Planned carotid endarterectomy
7. Intracranial bleeding or cerebral tumour
8. TIA or stroke caused by vasculitis, migraine, or dissection
9. Severe hypertension
10. Liver failure
11. Pregnancy
12. Chronic alcohol abuse
Anticipated start date 01/07/1997
Anticipated end date 01/12/2006
Status of trial Completed
Patient information material
Target number of participants 2,739
Interventions Secondary prevention after transient ischaemic attack or non-disabling ischaemic stroke.

Three treatment strategies:
1. Oral anticoagulation (international normalised ratio [INR] 2.0-3.0)
2. The combination of aspirin (acetylsalicylic acid [ASA]) (in any dose between 30 mg and 325 mg daily) and dipyridamole (400 mg daily)
3. ASA (in any dose between 30 mg and 325 mg daily)
Primary outcome measure(s) Composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever happened first.
Secondary outcome measure(s) 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
Sources of funding 1. Netherlands Heart Foundation (Netherlands)
2. UK Stroke Association (UK)
3. University Medical Center Utrecht (Netherlands)
4. Janivo Foundation (Netherlands)
5. French Ministry of Health (France)
6. Netherlands Thrombosis Foundation (Netherlands)
7. European Commission (ref: QLK6-CT-2002-02332)
Trial website
Publications 1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16714187
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22642755
Contact name Dr  Ale  Algra
  Address University Medical Center Utrecht
PO Box 85500
Mailbox STR 6.131
  City/town Utrecht
  Zip/Postcode 3508 GA
  Country Netherlands
Sponsor University Medical Center Utrecht (Netherlands)
  Address PO Box 85500
Room H.02.128
  City/town Utrecht
  Zip/Postcode 3508 GA
  Country Netherlands
  Tel +31 30 2508350
  Fax +31 30 2522782
  Email p.h.a.halkes@neuro.azu.nl
Date applied 23/06/2004
Last edited 12/08/2013
Date ISRCTN assigned 28/09/2004
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