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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
fibrinolytic therapy or combination reduced fibrinolytic therapy
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: inclusion into GUSTO V Exclusion Criteria: lack of availability of data (database study)

Sites / Locations

  • NYU School of Medicine

Outcomes

Primary Outcome Measures

Primary Outcome
All cause mortality at 30 days after randomization.

Secondary Outcome Measures

Secondary Outcomes
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.

Full Information

First Posted
October 27, 2005
Last Updated
October 3, 2012
Sponsor
NYU Langone Health
Collaborators
The Cleveland Clinic, Centocor, Inc., Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00245648
Brief Title
Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI
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 Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NYU Langone Health
Collaborators
The Cleveland Clinic, Centocor, Inc., Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
This study evaluated differences between men and women in the presentation, management and outcome of heart attacks within the GUSTO V study.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fibrinolytic therapy or combination reduced fibrinolytic therapy
Primary Outcome Measure Information:
Title
Primary Outcome
Description
All cause mortality at 30 days after randomization.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Secondary Outcomes
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: inclusion into GUSTO V Exclusion Criteria: lack of availability of data (database study)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harmony Reynolds
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11425410
Citation
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.
Results Reference
background
PubMed Identifier
12413372
Citation
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.
Results Reference
background
PubMed Identifier
17954798
Citation
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.
Results Reference
derived

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

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