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Titolo:
THE FEASIBILITY OF A COLLABORATIVE DOUBLE-BLIND-STUDY USING AN ANTICOAGULANT
Autore:
MOHR JP; SACCO RL; FLEISS J; LAZAR RM; THOMPSON JLP; GOHS D; LYNN L; BURROUGHS D; CAPUTO A; COLEMAN M; COSTIGAN T; FIELDS B; KANN G; KIM JS; KING R; MA W; RUZICKA JL; SLANE K; ZIDEL A; TILLEY BC; SCIACCA R; ROSNER B; WENDE K; LEVIN B; ADAMS HP; ALTER M; KISTLER JP; PETTIGREW LC; PULLICINO P; BREY RL; FELDMANN E; KITTNER SJ; BABIKIAN V; HOMMA SH; DITULLIO M; GREENBERG S; TREVISAN M; FISHER CM; BARNETT HJM; WISNANT JP; GAUTIER JC; SANDERCOCK P; KARANJIA P; BUONANNO FS; ALBERS G; NICHOLS F; GROTTA J; HELGASON C; RAMIREZLASSEPAS M; TUHRIM S; PESSIN M; CULEBRAS A; SILA C; CHIMOWITZ M; WEINREB H; BRASS L; WARACH S; KASE C; HAMILL R; ROSENBAUM D; HOLLANDER J; JOHNSON C; GAINES K; YASEEN M; MITSIAS P; LIBMAN R; NAFZIGER A; FORTEZA A; MILLER A; BILLER J; KIRSCHNER H; HALEY E; BINDER J; ZALEWSKI M; JAMIESON D; ANDERSON D; DANDAPANI B; LENNIHAN L; WINKELMAN M; HUGHES R; JACKSON C; BOOP B; CHATURVEDI S; ROTHROCK J; FREY AZ; DYKEN ML; LOWE A; MARLER JR; MEISSNER I; SHERMAN DG; TAYLOR DW; WALKER MD;
Indirizzi:
NEUROL INST,710 W 168TH ST,ROOM 513 NEW YORK NY 10032 COLUMBIA PRESBYTERIAN MED CTR NEW YORK NY 10032 HENRY FORD HLTH SCI CTR DETROIT MI 00000 MASSACHUSETTS GEN HOSP BOSTON MA 02114 BUFFALO GEN HOSP BUFFALO NY 14203
Titolo Testata:
Cerebrovascular diseases
fascicolo: 2, volume: 7, anno: 1997,
pagine: 100 - 112
SICI:
1015-9770(1997)7:2<100:TFOACD>2.0.ZU;2-6
Fonte:
ISI
Lingua:
ENG
Soggetto:
ANGIOTENSIN-CONVERTING-ENZYME; PATENT FORAMEN OVALE; TREATMENT RANDOMIZATION SYSTEM; ANTIPHOSPHOLIPID ANTIBODIES; ATRIAL-FIBRILLATION; DELETION POLYMORPHISM; RISK FACTOR; ANTICARDIOLIPIN ANTIBODIES; MYOCARDIAL-INFARCTION; PATIENT REGISTRATION;
Keywords:
ASPIRIN; ANTICOAGULANTS; PLATELET AGGREGATION; STROKE OUTCOME; WARFARIN; ANTIPHOSPHOLIPID ANTIBODIES; LUPUS ANTICOAGULANT; PATENT FORAMEN OVALE; COAGULATION;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
59
Recensione:
Indirizzi per estratti:
Citazione:
J.P. Mohr et al., "THE FEASIBILITY OF A COLLABORATIVE DOUBLE-BLIND-STUDY USING AN ANTICOAGULANT", Cerebrovascular diseases, 7(2), 1997, pp. 100-112

Abstract

We present the methodology and data indicating the feasibility of a five-study collaborative stroke trial, The core study, the Warfarin-Aspirin Recurrent Stroke Study (WARSS), is a prospective, randomized, double-blind multicenter trial comparing warfarin and aspirin in preventing the recurrence of ischemic stroke. The WARSS primary endpoint is the earlier of death or symptomatic ischemic stroke recurrence, The primary null hypothesis is that, over 2 years, warfarin therapy will not differ in frequency of death or ischemic stroke recurrence compared with platelet antiaggregant therapy (aspirin). The target sample size is 1,920, Four related studies use the WARSS data. The Antiphospholipid Antibodies and Stroke Study (APASS) investigates the significance of antiphospholipid antibodies in ischemic stroke; the Patent Foramen Ovalein Cryptogenic Stroke Study (PICSS) assesses the risk of stroke recurrence or systemic embolization in medically treated cryptogenic strokepatients with and without patent foramen ovale; and the Hemostatic System Activation Study (HAS) studies the F1 + 2 fractions of prothrombin in a subgroup of patients to allow comparison between the international normalized ratio (INR) and the evidence of prothrombin split products activity. The Genes in Stroke Study (GENESIS) investigates whetherthe double deletion genotype of the angiotensin converting enzyme is a risk factor for stroke. Features of the collaboration are cost savings in research arising from the use of a common data base; standardization through use of one central laboratory for processing of INR values, and double blinding by fabrication of INR values for aspirin patients, WARSS randomization began June 22, 1993. Cumulative patient recruitment through June 1, 1996 exceeds 1,400 at 50 sites.

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Documento generato il 29/11/20 alle ore 00:11:23