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

NCT ID: NCT00245648

Last Updated: 2012-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2007-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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fibrinolytic therapy or combination reduced fibrinolytic therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* inclusion into GUSTO V

Exclusion Criteria

* lack of availability of data (database study)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role collaborator

Centocor, Inc.

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Harmony R. Reynolds

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harmony Reynolds

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

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NYU School of Medicine

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11425410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12413372 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17954798 (View on PubMed)

Other Identifiers

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GUSTOVsex

Identifier Type: -

Identifier Source: org_study_id