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Comparison of Two Treatment Strategies in Patients With an Acute Coronary Syndrome Without ST Elevation

NCT00445263 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2015-02-27

Study results available
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Summary

The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main evolutionary risk of these patients is the coronary thrombosis and its self complications. The platelets aggregation plays a major role in the physiopathology of the ACS. The therapeutic arsenal of the anti-thrombosis essentially resting on aspirin and heparin has been reinforced lately by the inhibitors of the glycoprotein anti GP IIb/IIIa. The profit of these products in the ACS with or without ST elevation, associated or not to coronarography, has clearly been demonstrated. This profit is more marked when patients are at high risk of complications. Thus, the use of an anti GP IIb/IIIa is recommended among patients at "high risk" for whom a coronarography is planned, in the last international recommendations of the European Cardiology Society (ESC), the American Heart Association and the American College of Chest Physician. Otherwise, some authors have proposed An early invasive strategy based on coronarography with discordant results. The ideal delay of realization of this coronarography is unknown. It varies according to the studies between 2.5 hours to 48 hours. Once again, patients at high risk seem to benefit the more of such a strategy if it is set precociously.

Objective To compare an invasive strategy associating an early administration of tirofiban and a coronarography achieved in the 6 hours after the randomization to a conservative strategy in a population of high risk patients with ACS without ST elevation.

Design Multicentric, prospective, randomized study.

Conditions

  • CORONARY DISEASE

Interventions

DRUG

TIROFIBAN

intravenous infusion

PROCEDURE

CORONAROGRAPHY

standard procedure of coronarography

Sponsors & Collaborators

  • Hospital Avicenne

    lead OTHER

Principal Investigators

  • FREDERIC LAPOSTOLLE, MD · SAMU 93 - AVICENNE HOSPITAL

  • FREDERIC ADNET, PHD · SAMU 93 - AVICENNE HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-12-31
Completion
2013-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00445263 on ClinicalTrials.gov