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

NCT00445263 | Terminated Phase 4 Results DMC

• 1 other identifier: PC/AP 39-2005
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

CORONARY DISEASE

Keywords

CORONARY DISEASE

Outcome Measures

Primary Outcomes (1)

• Mortality, Myocardial Infarction and Revascularization in Emergency

  d30

Secondary Outcomes (3)

• Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography

  until the exit from the hospital and at d30.

• Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus

  d30

• Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.

  d30

Study Arms (2)

Early Invasive strategy

EXPERIMENTAL

Tirofiban and coronarography within 6 hours

Drug: TIROFIBAN; Procedure: CORONAROGRAPHY

Delayed invasive strategy

ACTIVE COMPARATOR

Coronarography after 6 hours

Procedure: CORONAROGRAPHY

Interventions

TIROFIBAN DRUG

intravenous infusion

Also known as: IIb/IIIa GP inhibitor

Early Invasive strategy

CORONAROGRAPHY PROCEDURE

standard procedure of coronarography

Also known as: angiography

Delayed invasive strategy; Early Invasive strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High risk ACS without ST elevation

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Avicenne: lead

Study Sites (1)

Samu 93 - Chu Avicenne

Bobigny, Île-de-France Region, 93000, France

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Tirofiban; Cerebral Angiography

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Neurological; Investigative Techniques

Results Point of Contact

• Title: Pr Frédéric Lapostolle
• Organization: SAMU 93

frederic.lapostolle@avc.aphp.fr

0033148964454

Study Officials

• FREDERIC LAPOSTOLLE, MD

  SAMU 93 - AVICENNE HOSPITAL

  PRINCIPAL INVESTIGATOR

• FREDERIC ADNET, PHD

  SAMU 93 - AVICENNE HOSPITAL

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Frédéric Lapostolle

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: July 1, 2013
• Last Updated: February 27, 2015
• Results First Posted: February 9, 2015

Record last verified: 2015-02

Locations

FR (1)