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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00445263
Recruitment Status : Terminated (Because of inclusion delay)
First Posted : March 8, 2007
Results First Posted : February 9, 2015
Last Update Posted : February 27, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase

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  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Early Invasive strategy
Tirofiban and coronarography within 6 hours
intravenous infusion
Other Name: IIb/IIIa GP inhibitor
standard procedure of coronarography
Other Name: angiography
Active Comparator: Delayed invasive strategy
Coronarography after 6 hours
standard procedure of coronarography
Other Name: angiography

Primary Outcome Measures :
  1. Mortality, Myocardial Infarction and Revascularization in Emergency [ Time Frame: d30 ]

Secondary Outcome Measures :
  1. Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography [ Time Frame: until the exit from the hospital and at d30. ]
  2. Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus [ Time Frame: d30 ]
  3. Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications. [ Time Frame: d30 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00445263

Samu 93 - Chu Avicenne
Bobigny, Ile de France, France, 93000
Sponsors and Collaborators
Hospital Avicenne

Responsible Party: FREDERIC LAPOSTOLLE, Frédéric Lapostolle, Hospital Avicenne Identifier: NCT00445263     History of Changes
Other Study ID Numbers: PC/AP 39-2005
First Posted: March 8, 2007    Key Record Dates
Results First Posted: February 9, 2015
Last Update Posted: February 27, 2015
Last Verified: February 2015

Keywords provided by FREDERIC LAPOSTOLLE, Hospital Avicenne:

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors