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

Tracking Information

First Received Date ^ICMJE

October 27, 2005

Last Updated Date

October 27, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment

Condition ^ICMJE

Myocardial Infarcton

Intervention ^ICMJE

Drug: fibrinolytic therapy or combination reduced fibrinolytic therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

inclusion into GUSTO V

Exclusion Criteria:

lack of availability of data (database study)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00245648

Responsible Party

Study ID Numbers ^ICMJE

GUSTOVsex

Study Sponsor ^ICMJE

New York University School of Medicine

Collaborators ^ICMJE

The Cleveland Clinic
Centocor, Inc.
Eli Lilly and Company

Investigators ^ICMJE

Principal Investigator:

Harmony Reynolds

NYU School of Medicine

Information Provided By

New York University School of Medicine

Verification Date

June 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP