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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Hospital Avicenne.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Avicenne
ClinicalTrials.gov Identifier:
NCT00445263
First received: March 7, 2007
Last updated: March 14, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Coronary Disease
Drug: TIROFIBAN
Procedure: CORONAROGRAPHY
Phase 4

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

Further study details as provided by Hospital Avicenne:

Primary Outcome Measures:
  • Mortality, myocardial infarction and revascularization in emergency at d30

Secondary Outcome Measures:
  • 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
  • Troponin peak. Left ventricular ejection fraction before hospital exit. Length of stay in USIC and hospital. Hemorrhagic complications.

Estimated Enrollment: 480
Study Start Date: March 2007
Estimated Study Completion Date: December 2008
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445263

Contacts
Contact: FREDERIC LAPOSTOLLE, MD +33 148964454 frederic.lapostolle@avc.aphp.fr
Contact: FREDERIC ADNET, PHD +33 148964408 frederic.adnet@avc.aphp.fr

Locations
France
Samu 93 - Chu Avicenne Recruiting
Bobigny, Ile de France, France, 93000
Contact: FREDERIC LAPOSTOLLE, MD    +33148964454    frederic.lapostolle@avc.aphp.fr   
Principal Investigator: FREDERIC LAPOSTOLLE, MD         
Sub-Investigator: FREDERIC ADNET, PHD         
Sub-Investigator: MICHEL GALINSKI, MD         
Sponsors and Collaborators
Hospital Avicenne
Investigators
Principal Investigator: FREDERIC LAPOSTOLLE, MD SAMU 93 - AVICENNE HOSPITAL
Study Director: FREDERIC ADNET, PHD SAMU 93 - AVICENNE HOSPITAL
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00445263     History of Changes
Other Study ID Numbers: PC/AP 39-2005
Study First Received: March 7, 2007
Last Updated: March 14, 2007
Health Authority: France: Institutional Ethical Committee

Keywords provided by Hospital Avicenne:
CORONARY DISEASE

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Artery Disease
Coronary Disease
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014