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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
Sponsor:
Collaborators:
The Cleveland Clinic
Centocor, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
Harmony R. Reynolds, NYU Langone Health

Study Description
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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
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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
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

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Arms and Interventions
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Outcome Measures
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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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • inclusion into GUSTO V

Exclusion Criteria:

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


Locations
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United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
The Cleveland Clinic
Centocor, Inc.
Eli Lilly and Company
Investigators
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Principal Investigator: Harmony Reynolds NYU School of Medicine
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Harmony R. Reynolds, Assistant Professor, NYU Langone Health
ClinicalTrials.gov Identifier: NCT00245648    
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:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases