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

Phase 3

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT00245648
• Lead Sponsor: NYU Langone Health

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 Timeline

• Study Start: 2001-06
• Study First Submitted: 2005-10-27
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-28
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• inclusion into GUSTO V

Exclusion Criteria

• lack of availability of data (database study)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Outcome	30 days	All cause mortality at 30 days after randomization.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcomes	7 days	Incidence of myocardial reinfarction as evidenced by new electrocardiographic changes or elevation in cardiac enzyme levels with recurrent chest pain within 7 days, bleeding, stoke, intracranial hemorrhage (ICH), and complications of MI.

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States