ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial
Keywords
Coimriú
Cur síos
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.
Dátaí
| Fíoraithe Deireanach: | 02/28/2007 |
| Cuireadh isteach den chéad uair: | 09/07/2005 |
| Clárú Measta Curtha isteach: | 09/07/2005 |
| Arna chur suas ar dtús: | 09/11/2005 |
| Nuashonrú Deireanach Curtha isteach: | 03/20/2007 |
| Nuashonrú Deireanach Postáilte: | 03/21/2007 |
| Dáta Tosaigh an Staidéir Iarbhír: | 06/30/1997 |
| Dáta Críochnaithe an Staid Mheasta: | 11/30/2006 |
Coinníoll nó galar
Idirghabháil / cóireáil
Drug: anticoagulation
Drug: aspirin and dipyridamole
Drug: aspirin alone
Céim
Critéir Incháilitheachta
| Aois Incháilithe le haghaidh Staidéir | 18 Years Chun 18 Years |
| Gnéas Incháilithe le haghaidh Staidéir | All |
| Glacann Oibrithe Deonacha Sláintiúla | Sea |
| Critéir | 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 |
Toradh
Bearta Toraidh Príomhúla
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 [undefined]
Bearta Torthaí Tánaisteacha
1. Death from all causes [undefined]
2. death from vascular causes [undefined]
3. death from vascular causes or nonfatal stroke [undefined]
4. fatal or nonfatal stroke [undefined]
5. death from vascular causes, nonfatal stroke, nonfatal myocardial infarction or vascular intervention [undefined]
6. major bleeding complications [undefined]
7. amputations of lower extremities [undefined]
8. retinal infarction or bleeding [undefined]
