Clinical trial NCT00445263: Comparison of Two Treatment Strategies in Patients With an Acute Coronary Syndrome Without ST Elevation
Official title: Treatment by Anti GP IIb/IIIa in the Setting of a Strategy of Early Coronarography to Patients With an Acute Coronary Syndrome Without ST Elevation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: CORONARY DISEASE
Keywords: CORONARY DISEASE
Lead sponsor: Hospital Avicenne
Sponsor class: OTHER
First posted: 2007-03-08
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Mortality, Myocardial Infarction and Revascularization in Emergency
timeFrame: d30
Secondary outcomes:
measure: Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography
timeFrame: until the exit from the hospital and at d30.
measure: Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus
timeFrame: d30
measure: Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.
timeFrame: d30
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Samu 93 - Chu Avicenne
state: Ile de France
Study officials:
affiliation: SAMU 93 - AVICENNE HOSPITAL
name: FREDERIC LAPOSTOLLE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SAMU 93 - AVICENNE HOSPITAL
name: FREDERIC ADNET, PHD
role: STUDY_DIRECTOR
References: