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

CORONARY DISEASE Clinical Trial

— SISCA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00445263
• Other study ID #: PC/AP 39-2005
• Status: Terminated
• Phase: Phase 4
• First received: March 7, 2007
• Last updated: February 9, 2015
• Start date: March 2007
• Est. completion date: July 2013

Study information

• Verified date: February 2015
• Source: Hospital Avicenne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 170
• Est. completion date: July 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease

Intervention

Drug:
• TIROFIBAN
intravenous infusion

Procedure:
• CORONAROGRAPHY
standard procedure of coronarography

Locations

Country	Name	City	State
France	Samu 93 - Chu Avicenne	Bobigny	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Avicenne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality, Myocardial Infarction and Revascularization in Emergency		d30	No
Secondary	Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography		until the exit from the hospital and at d30.	No
Secondary	Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus		d30	No
Secondary	Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.		d30	No