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

February 9, 2015 updated by: FREDERIC LAPOSTOLLE, Hospital Avicenne

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Bobigny, Ile de France, France, 93000
        • Samu 93 - Chu Avicenne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Invasive strategy
Tirofiban and coronarography within 6 hours
Drug: TIROFIBAN
intravenous infusion
Other Names:
  • IIb/IIIa GP inhibitor
Procedure: CORONAROGRAPHY
standard procedure of coronarography
Other Names:
  • angiography
Active Comparator: Delayed invasive strategy
Coronarography after 6 hours
Procedure: CORONAROGRAPHY
standard procedure of coronarography
Other Names:
  • angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality, Myocardial Infarction and Revascularization in Emergency
Time Frame: d30
d30

Secondary Outcome Measures

Outcome Measure
Time Frame
Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography
Time Frame: until the exit from the hospital and at d30.
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
Time Frame: d30
d30
Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.
Time Frame: d30
d30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Avicenne

Investigators

  • Principal Investigator: FREDERIC LAPOSTOLLE, MD, SAMU 93 - AVICENNE HOSPITAL
  • Study Director: FREDERIC ADNET, PHD, SAMU 93 - AVICENNE HOSPITAL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Estimate)

February 27, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC/AP 39-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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