Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI
October 3, 2012 updated by: Harmony R. Reynolds, NYU Langone Health
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
This study evaluated differences between men and women in the presentation, management and outcome of heart attacks within the GUSTO V study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- inclusion into GUSTO V
Exclusion Criteria:
- lack of availability of data (database study)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Outcome
Time Frame: 30 days
|
All cause mortality at 30 days after randomization.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harmony Reynolds, NYU School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Topol EJ; GUSTO V Investigators. Reperfusion therapy for acute myocardial infarction with fibrinolytic therapy or combination reduced fibrinolytic therapy and platelet glycoprotein IIb/IIIa inhibition: the GUSTO V randomised trial. Lancet. 2001 Jun 16;357(9272):1905-14. doi: 10.1016/s0140-6736(00)05059-5.
- Lincoff AM, Califf RM, Van de Werf F, Willerson JT, White HD, Armstrong PW, Guetta V, Gibler WB, Hochman JS, Bode C, Vahanian A, Steg PG, Ardissino D, Savonitto S, Bar F, Sadowski Z, Betriu A, Booth JE, Wolski K, Waller M, Topol EJ; Global Use of Strategies To Open Coronary Arteries Investigators (GUSTO). Mortality at 1 year with combination platelet glycoprotein IIb/IIIa inhibition and reduced-dose fibrinolytic therapy vs conventional fibrinolytic therapy for acute myocardial infarction: GUSTO V randomized trial. JAMA. 2002 Nov 6;288(17):2130-5. doi: 10.1001/jama.288.17.2130.
- Reynolds HR, Farkouh ME, Lincoff AM, Hsu A, Swahn E, Sadowski ZP, White JA, Topol EJ, Hochman JS; GUSTO V Investigators. Impact of female sex on death and bleeding after fibrinolytic treatment of myocardial infarction in GUSTO V. Arch Intern Med. 2007 Oct 22;167(19):2054-60. doi: 10.1001/archinte.167.19.2054.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2001
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
October 27, 2005
First Submitted That Met QC Criteria
October 27, 2005
First Posted (Estimate)
October 28, 2005
Study Record Updates
Last Update Posted (Estimate)
October 4, 2012
Last Update Submitted That Met QC Criteria
October 3, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GUSTOVsex
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.