The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 756 for:    Fibrinolytic Therapy | Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation Studies | Industry
Previous Study | Return to List | Next Study

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

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.
 
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Harmony Reynolds NYU School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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

Layout table for additonal information
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:
Layout table for MeSH terms
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases