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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Invasive strategy | Experimental | Tirofiban and coronarography within 6 hours |
|
| Delayed invasive strategy | Active Comparator | Coronarography after 6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIROFIBAN | Drug | intravenous infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality, Myocardial Infarction and Revascularization in Emergency | d30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| FREDERIC LAPOSTOLLE, MD | SAMU 93 - AVICENNE HOSPITAL | Principal Investigator |
| FREDERIC ADNET, PHD | SAMU 93 - AVICENNE HOSPITAL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samu 93 - Chu Avicenne | Bobigny | ÃŽle-de-France Region | 93000 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Invasive Strategy | Tirofiban and coronarography within six hours |
| FG001 | Delayed Invasive Strategy | Coronarography after six hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Invasive Strategy | Tirofiban and coronarography within six hours |
| BG001 | Delayed Invasive Strategy | Coronarography after six hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality, Myocardial Infarction and Revascularization in Emergency | Posted | Number | participants | d30 |
|
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Invasive Strategy | Tirofiban and coronarography within six hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major bleeding | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Frédéric Lapostolle | SAMU 93 | 0033148964454 | frederic.lapostolle@avc.aphp.fr |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| D002533 | Cerebral Angiography |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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| CORONAROGRAPHY | Procedure | standard procedure of coronarography |
|
|
| d30 |
| Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications. | d30 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m2 |
|
| Family history of CVS disease | Number | participants |
|
| Current smoker | Number | participants |
|
| Diabetes mellitus | Number | participants |
|
| Hypertension | Number | participants |
|
| Dyslipidemia | Number | participants |
|
| Previous MI | Number | participants |
|
| Previous PCI | Number | participants |
|
| Previous CABG | Number | participants |
|
| On aspirin | Number | participants |
|
|
| Secondary | Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography | Not Posted | until the exit from the hospital and at d30. |
| Secondary | Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus | Not Posted | d30 |
| Secondary | Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications. | Not Posted | d30 |
| 2 |
| 83 |
| 0 |
| 83 |
| EG001 | Delayed Invasive Strategy | Coronarography after six hours | 1 | 86 | 0 | 86 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000792 | Angiography |
| D011859 | Radiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |