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

This study has been completed.
The Cleveland Clinic
Centocor, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
Harmony R. Reynolds, New York University School of Medicine Identifier:
First received: October 27, 2005
Last updated: October 3, 2012
Last verified: October 2012

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 Infarction
Drug: fibrinolytic therapy or combination reduced fibrinolytic therapy
Phase 3

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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Primary Outcome [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    All cause mortality at 30 days after randomization.

Secondary Outcome Measures:
  • Secondary Outcomes [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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.

Study Start Date: June 2001
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • inclusion into GUSTO V

Exclusion Criteria:

  • lack of availability of data (database study)
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Please refer to this study by its identifier: NCT00245648

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
Principal Investigator: Harmony Reynolds NYU School of Medicine
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Harmony R. Reynolds, Assistant Professor, New York University School of Medicine Identifier: NCT00245648     History of Changes
Other Study ID Numbers: GUSTOVsex
Study First Received: October 27, 2005
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Tissue Plasminogen Activator
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 24, 2014