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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.
Sponsor:
Collaborators:
The Cleveland Clinic
Centocor, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
Harmony R. Reynolds, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00245648
First received: October 27, 2005
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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:

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

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.

  Eligibility

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

Inclusion Criteria:

  • inclusion into GUSTO V

Exclusion Criteria:

  • lack of availability of data (database study)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245648

Locations
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
Investigators
Principal Investigator: Harmony Reynolds NYU School of Medicine
  More Information

Publications:

Additional 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
Study First Received: October 27, 2005
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Infarction
Myocardial Infarction
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on May 22, 2013