Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445263
Status:
TERMINATED
Last Update Posted:
2015-02-27
First Post:
2007-03-07
Brief Title:
Comparison of Two Treatment Strategies in Patients With an Acute Coronary Syndrome Without ST Elevation
Sponsor:
Hospital Avicenne
Organization:
Hospital Avicenne
Study Overview
Official Title:
Treatment by Anti GP IIbIIIa in the Setting of a Strategy of Early Coronarography to Patients With an Acute Coronary Syndrome Without ST Elevation
Status:
TERMINATED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Because of inclusion delay
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SISCA
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 IIbIIIa 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 IIbIIIa 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 25 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
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
Detailed Description:
Patients 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 clinicians appreciation Besides either they receive an anti GP IIbIIIa 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
Therapeutic modes All patients receive aspirin clopidogrel enoxaparine Trinitrin and analgesics are at the clinicians appreciation Besides either they receive an anti GP IIbIIIa 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None