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

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ClinicalTrials.gov Identifier: NCT00245648
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : October 4, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: fibrinolytic therapy or combination reduced fibrinolytic therapy Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2001
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Primary Outcome [ Time Frame: 30 days ]
    All cause mortality at 30 days after randomization.

Secondary Outcome Measures :
  1. Secondary Outcomes [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • inclusion into GUSTO V

Exclusion Criteria:

  • lack of availability of data (database study)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harmony R. Reynolds, Assistant Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00245648     History of Changes
Other Study ID Numbers: GUSTOVsex
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action