Skip to content

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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00245648
Enrollment
Unknown
Registered
2005-10-28
Start date
2001-06-30
Completion date
2007-10-31
Last updated
2012-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

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.

Interventions

DRUGfibrinolytic therapy or combination reduced fibrinolytic therapy

Sponsors

The Cleveland Clinic
CollaboratorOTHER
Centocor, Inc.
CollaboratorINDUSTRY
Eli Lilly and Company
CollaboratorINDUSTRY
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* inclusion into GUSTO V

Exclusion criteria

* lack of availability of data (database study)

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome30 daysAll cause mortality at 30 days after randomization.

Secondary

MeasureTime frameDescription
Secondary Outcomes7 daysIncidence 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026