We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00245648
First Posted: October 28, 2005
Last Update Posted: October 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Cleveland Clinic
Centocor, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
Harmony R. Reynolds, New York University School of Medicine
  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
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

Resource links provided by NLM:


Further study details as provided by Harmony R. Reynolds, New York University School of Medicine:

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


Secondary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


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:
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 Submitted: October 27, 2005
First Posted: October 28, 2005
Last Update Posted: October 4, 2012
Last Verified: October 2012

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