@article{67d544ef25a744318512957d94a721ba,
title = "A randomized trial of anticoagulants versus aspirin after cerebral ischemia of presumed arterial origin",
abstract = "Aspirin is only modestly effective in the secondary prevention after cerebral ischemia Studies in other vascular disorders suggest that anticoagulant drugs in patients with cerebral ischemia of presumed arterial (noncardiac) origin might be more effective. The aim of the Stroke Prevention in Reversible Ischemia Trial (SPIRIT) therefore was to compare the efficacy and safety of 30 mg aspirin daily and oral anticoagulation (international normalized ratio [INR] 3.0-4.5), Patients referred to a neurologist in one of 58 collaborating centers because of a transient ischemic attack or minor ischemic stroke (Rankin grade less than or equal to 3) were eligible. Randomization was concealed, treatment assignment was open, and assessment of outcome events was masked. The primary measure of outcome was the composite event {"}death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction, or nonfatal major bleeding complication.{"} The trial was stopped at the first interim analysis. A total of 1,316 patients participated; their mean follow-up was 14 months. There was an excess of the primary outcome event in the anticoagulated group (81 of 651) versus 36 of 665 in the aspirin group (hazard ratio, 2.3; 95% confidence interval [CI], 1.6-3.5). This excess could be attributed to 53 major bleeding complications (27 intracranial; 17 fatal) during anticoagulant therapy versus 6 on aspirin (3 intracranial; 1 fatal). The bleeding incidence increased by a factor of 1.43 (95% CI, 0.96-2.13) for each 0.5 unit increase of the achieved INR. Anticoagulant therapy with an INR range of 3.0 to 4.5 in patients after cerebral ischemia of presumed arterial origin is not safe. The efficacy of a lower intensity anticoagulation regimen remains to be determined.",
keywords = "ACUTE MYOCARDIAL-INFARCTION, INTRACEREBRAL HEMORRHAGE, INTEROBSERVER AGREEMENT, BLEEDING COMPLICATIONS, OPTIMAL INTENSITY, STROKE PATIENTS, THERAPY, WARFARIN, HANDICAP, DISEASE",
author = "{SPIRIT Study Grp} and CL Franke and PJJ Koehler and JW Gorter and LJ Kappelle and GJE Rinkel and HC Tjeerdsma and {van Gijn}, J and JWHH Dammers and HJS Straatman and {ten Houten}, R and MM Veering and SLM Bakker and D Dippel and PJ Koudstaal and {van Gemert}, HMA and {van Swieten}, JC and J Horn and IH Kwa and M Limburg and J Stam and AM Boon and WHG Lieuwens and F Visscher and C Bouwsma and AWF Rutgers and JW Snoek and PJAM Brouwers and J Nihom and H Solleveld and PAT Carbaat and LI Hertzberger and RP Kleijweg and {Nanninga-van den Neste}, VMH and {van Diepen}, AJH and WHJP Linssen and JAL Vanneste and J Vos and HC Weinstein and JP Schipper and {van der Meer}, WK and PJIM Berntsen and {de Vries-Leenders}, EM and JP Geervliet and RJJ Tans and WJ Feikema and HJHM Lohmann and {van Kasteel} and FA Jongebloed and QH Leyten and {van Wensen}, PJM and C Jansen and MG Smits and JJM Driesen and {van Oudenaarden}, WF and JCB Verhey and HRF Bottger and MF Driessen-Kletter and F Zwols and {van der Gaast}, JB and MC Wittebol and J Lodder and {van Oostenbrugge}, RJ and KD Beintema and J Hilbers and {van der Weil}, HL and {van Lieshout}, HBM and W Weststrate and PLJA Bernsen and CWGM Frenken and EFJ Poels and SF Lindeboom and {van der Steen}, A and WF Glimmerveen and EIF Martens and C Bulens and {de Vries-Bos}, LHP and GS Venables and JG Koster and LGF Sinnige and MM Klaver and JC Koetsveld-Baart and HW Mauser and JA Don and {van Geusau}, RBA and MH Dijkman and WJJF Hoppenbrouwers and WJJF Banford and PE Briet and JLA Eekhof and R Witjes and HL Hamburger and {van der Sande}, JJ and P Bath and GJ Hankey and E Koning and S Ricci and JN Berendes and LJMA Hooff and {van Spreeken}, ACGA and HNA Wouters and AR Kuhler and GN Mallo and {van Walbeek}, HK and JC Gauw and AJ Vermeij and JCB Verheij and JWA Swen and P Canhao and A Keyser and RS Holscher and {de Jong}, GJ and Kraaier and A Algra and E Briet and J deVries-Goldschemdingi and BC Eikelboom and P Greebe and RNW Hauer and MG Hermsen and EA Loeliger and GAM Pop and FR Rosendaal and AFAM Schobben and ML Simoons and FF Sixma and DCV Slabbers and JCP Tijssen and {van Creval}, H and {van Es}, GA and FWA Verheugt and M Vermeulin and EFD Wever and EKM Wulfsen",
year = "1997",
month = dec,
language = "English",
volume = "42",
pages = "857--865",
journal = "Annals of Neurology",
issn = "0364-5134",
publisher = "Wiley-Blackwell",
number = "6",
}