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| [ ...Back to search results ] | [ Print-friendly version ] |
| European/Australasian Stroke Prevention in Reversible Ischaemia Trial |
| ISRCTN | ISRCTN73824458 |
| ClinicalTrials.gov identifier | NCT00161070 |
| 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 | |
| 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 | 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16714187 |
| 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 |
| p.h.a.halkes@neuro.azu.nl | |
| Date applied | 23/06/2004 |
| Last edited | 09/09/2009 |
| Date ISRCTN assigned | 28/09/2004 |
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| © 2012 ISRCTN unless otherwise stated. | |
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