Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI - Full Text View

Sponsors and Collaborators:	New York University School of Medicine The Cleveland Clinic Centocor, Inc. Eli Lilly and Company
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00245648

Purpose

This study evaluated differences between men and women in the presentation, management and outcome of heart attacks within the GUSTO V study.

Condition	Intervention	Phase
Myocardial Infarcton	Drug: fibrinolytic therapy or combination reduced fibrinolytic therapy	Phase III

Drug Information available for: Alteplase Tissue-type plasminogen activator Streptokinase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI; Results of the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries - V Trial

Further study details as provided by New York University School of Medicine:

Detailed Description:

The Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes (GUSTO) V trial examined a large, contemporary cohort of women and men with ST elevation myocardial infarction (STEMI) treated with fibrinolytic therapy. The objective of the present study was to evaluate sex differences in presentation, management and outcome in GUSTO V.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

inclusion into GUSTO V

Exclusion Criteria:

lack of availability of data (database study)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245648

Locations

United States, New York
NYU School of Medicine
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

The Cleveland Clinic

Centocor, Inc.

Eli Lilly and Company

Investigators

Principal Investigator:

Harmony Reynolds

NYU School of Medicine

More Information

Publications:

Topol EJ; GUSTO V Investigators. Reperfusion therapy for acute myocardial infarction with fibrinolytic therapy or combination reduced fibrinolytic therapy and platelet glycoprotein IIb/IIIa inhibition: the GUSTO V randomised trial. Lancet. 2001 Jun 16;357(9272):1905-14.

Lincoff AM, Califf RM, Van de Werf F, Willerson JT, White HD, Armstrong PW, Guetta V, Gibler WB, Hochman JS, Bode C, Vahanian A, Steg PG, Ardissino D, Savonitto S, Bar F, Sadowski Z, Betriu A, Booth JE, Wolski K, Waller M, Topol EJ; Global Use of Strategies To Open Coronary Arteries Investigators (GUSTO). Mortality at 1 year with combination platelet glycoprotein IIb/IIIa inhibition and reduced-dose fibrinolytic therapy vs conventional fibrinolytic therapy for acute myocardial infarction: GUSTO V randomized trial. JAMA. 2002 Nov 6;288(17):2130-5.

Publications indexed to this study:

Reynolds HR, Farkouh ME, Lincoff AM, Hsu A, Swahn E, Sadowski ZP, White JA, Topol EJ, Hochman JS; GUSTO V Investigators. Impact of female sex on death and bleeding after fibrinolytic treatment of myocardial infarction in GUSTO V. Arch Intern Med. 2007 Oct 22;167(19):2054-60.

Study ID Numbers:	GUSTOVsex
Study First Received:	October 27, 2005
Last Updated:	October 27, 2005
ClinicalTrials.gov Identifier:	NCT00245648
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Death
Tissue Plasminogen Activator
Streptokinase
Hemorrhage
Plasminogen

Additional relevant MeSH terms:

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009