Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This study evaluated differences between men and women in the presentation, management and outcome of heart attacks within the GUSTO V study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2001
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 27, 2005
CompletedFirst Posted
Study publicly available on registry
October 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedOctober 4, 2012
October 1, 2012
6.3 years
October 27, 2005
October 3, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Outcome
All cause mortality at 30 days after randomization.
30 days
Secondary Outcomes (1)
Secondary Outcomes
7 days
Interventions
Eligibility Criteria
You may not qualify if:
- lack of availability of data (database study)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- The Cleveland Cliniccollaborator
- Centocor, Inc.collaborator
- Eli Lilly and Companycollaborator
Study Sites (1)
NYU School of Medicine
New York, New York, 10016, United States
Related Publications (3)
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.
PMID: 11425410BACKGROUNDLincoff 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.
PMID: 12413372BACKGROUNDReynolds 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.
PMID: 17954798DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harmony Reynolds
NYU School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 27, 2005
First Posted
October 28, 2005
Study Start
June 1, 2001
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
October 4, 2012
Record last verified: 2012-10