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Titel:

Early treatment with aspirin plus extended-release dipyridamole for transient ischaemic attack or ischaemic stroke within 24 h of symptom onset (EARLY trial): a randomised, open-label, blinded-endpoint trial.

Dokumenttyp:
journal article
Autor(en):
Dengler, R; Diener, HC; Schwartz, A; Grond, M; Schumacher, H; Machnig, T; Eschenfelder, CC; Leonard, J; Weissenborn, K; Kastrup, A; Haberl, R; EARLY Investigators; Berrouschot, J; Stoll, A; Ickenstein, GW; Westendorf, T; Daffertshofer, M; Lachenicht, B; Szponar-Wolf, A; Krauseneck, P; Oschmann, P; Pott, M; Schultes, K; Wessel, K; Ahlers, A; Nabavi, DG; Crome, O; Endres, M; Jungehülsing, JG; Ebke, M; Schröter, A; Odin, P; von Mering, M; Heide, W; Hanssen, JR; Schrader, J; Lüders, S; Rudel, G; Jan...     »
Abstract:
Little is known about the best antiplatelet treatment immediately after ischaemic stroke or transient ischaemic attack (TIA). The EARLY trial aimed to compare outcome in patients given aspirin plus extended-release dipyridamole twice daily either within 24 h of stroke or TIA or after 7 days of aspirin monotherapy.In 46 stroke units in Germany, patients aged 18 years or more who presented with symptoms of an acute ischaemic stroke that caused a measurable neurological deficit (National Institutes of Health stroke scale score< or =20) were randomly assigned to receive 25 mg aspirin plus 200 mg extended-release dipyridamole open-label twice daily or 100 mg aspirin monotherapy open-label once daily for 7 days. Patients were randomised by use of a pseudorandom number generator. All patients were then given open-label aspirin plus extended-release dipyridamole for up to 90 days. The primary endpoint was modified Rankin scale score as recorded by centralised, blinded assessment by telephone (tele-mRS) at 90 days. Vascular adverse events (non-fatal stroke, TIA, non-fatal myocardial infarction, and major bleeding complications) and mortality were assessed in a composite safety and efficacy endpoint. Patients were analysed as treated. This trial is registered, number NCT00562588.Between July, 2007, and February, 2009, 543 patients were treated: 283 received early aspirin plus extended-release dipyridamole and 260 received aspirin plus extended-release dipyridamole after 7 days on aspirin. At day 90, 154 (56%) patients in the aspirin plusearly extended-release dipyridamole group and 133 (52%) in the aspirin plus later extended-release dipyridamole group had no or mild disability (tele-mRS 0 or 1; difference 4.1%, 95% CI -4.5 to 12.6, p=0.45). 28 patients in the early initiation group and 38 in the late initiation group reached the composite endpoint (hazard ratio 0.73, 95% CI 0.44-1.19 p=0.20).Early initiation of aspirin plus extended-release dipyridamole within 24 h of stroke onset is likely to be as safe and effective in preventing disability as is later initiation after 7 days.Boehringer Ingelheim.
Zeitschriftentitel:
Lancet Neurol
Jahr:
2010
Band / Volume:
9
Heft / Issue:
2
Seitenangaben Beitrag:
159-66
Sprache:
eng
PubMed:
http://view.ncbi.nlm.nih.gov/pubmed/20060783
Print-ISSN:
1474-4422
TUM Einrichtung:
Neurologische Klinik und Poliklinik
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