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Completed

NCT Number: NCT00245648

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

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

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NYU School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • inclusion into GUSTO V

Exclusion criteria

  • lack of availability of data (database study)

Treatment and study plan

fibrinolytic therapy or combination reduced fibrinolytic therapy

Drug

Primary outcomes

  1. Primary Outcome

    Time frame: 30 days

    All cause mortality at 30 days after randomization.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Centocor, Inc.
  • Eli Lilly and Company
  • The Cleveland Clinic

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Oct 28, 2005
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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