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

NCT ID: NCT00445263

Last Updated: 2015-02-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2013-07-31

Brief 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.

Detailed Description

Patient's selection Patient of more than 18 years with a ACS defined by a thoracic pain of more than 20 minutes that occurred during the last 24 hours, anomalies on EKG and one of the following criteria : diabetes; recurrence of coronary pain; precocious pain post-myocardial infarction; falling of the ST segment of > 1 mm; transient elevation of the ST segment > 1 mm; elevation of the I troponin, T troponin or CPK MB; hemodynamic instability; ventricular arrhythmia; TIMI score > 5

Therapeutic modes All patients receive : aspirin, clopidogrel, enoxaparine. Trinitrin and analgesics are at the clinician's appreciation. Besides, either they receive an anti GP IIb/IIIa: tirofiban (Agrastat®) and are oriented in cardiology to have a coronarography in the six hours or they are oriented in cardiology to receive the classical treatment, guided by the investigations searching for signs of myocardial ischemia.

Conditions

CORONARY DISEASE

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Invasive strategy

Tirofiban and coronarography within 6 hours

Group Type: EXPERIMENTAL

TIROFIBAN

Intervention Type: DRUG

intravenous infusion

CORONAROGRAPHY

Intervention Type: PROCEDURE

standard procedure of coronarography

Delayed invasive strategy

Coronarography after 6 hours

Group Type: ACTIVE_COMPARATOR

CORONAROGRAPHY

Intervention Type: PROCEDURE

standard procedure of coronarography

Interventions

TIROFIBAN

intravenous infusion

Intervention Type: DRUG

CORONAROGRAPHY

standard procedure of coronarography

Intervention Type: PROCEDURE

Other Intervention Names

IIb/IIIa GP inhibitor; angiography

Eligibility Criteria

Inclusion Criteria

• High risk ACS without ST elevation

Exclusion Criteria

• Age <18 years
• Pregnancy
• Persistence of the ST elevation
• Recent left branch block
• Cardiac failure or cardiogenic shock (Kilip 3 or 4)
• Treatment by anti-vitamin K
• Contra-indication to the use of one of the following treatments: aspirin, clopidogrel, enoxaparine, anti GP IIb/IIIa (tirofiban)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Avicenne

OTHER

Sponsor Role: lead

Responsible Party

FREDERIC LAPOSTOLLE

Frédéric Lapostolle

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

FREDERIC LAPOSTOLLE, MD

Role: PRINCIPAL_INVESTIGATOR

SAMU 93 - AVICENNE HOSPITAL

FREDERIC ADNET, PHD

Role: STUDY_DIRECTOR

SAMU 93 - AVICENNE HOSPITAL

Locations

Samu 93 - Chu Avicenne

Bobigny, Île-de-France Region, France

Countries

France

Other Identifiers

PC/AP 39-2005

Identifier Type: -

Identifier Source: org_study_id