Acute Myocardial Infarction
Conditions
Keywords
Acute myocardial infarction,, GPIIbIIIa inhibitors,, primary angioplasty,, tirofiban
Brief summary
In patients with acute myocardial infarction who are managed in the prehospital setting, and who will treated with primary angioplasty, we evaluate the benefit of an early administration of tirofiban, a powerful GPIIbIIIa inhibitors. Patients are randomised to early administration in the ambulance or administration in the cathlab. The primary endpoint is TIMI 2-3 flow in the first coronary opacification of the culprit artery.
Interventions
DRUGtirofiban
bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Information given to the patient and consent obtained * Thoracic pain or symptoms of infarction * Symptoms \< 12 hours * ST deviation identified by electrocardiography (ECG) in at least 2 contiguous leads * Transfer time to angioplasty room evaluated by the coordinating doctor as less than 90 minutes (from ECG diagnosis to arrival in angioplasty room)
Exclusion criteria
* Physiological or pathological conditions not compatible with a revascularisation procedure (in the acute phase of myocardial infarction (MI) * Administration of fibrinolytics or another antiGPIIBIIIa in the previous seven days * Contraindications to aspirin or tirofiban or heparin * Diagnosed severe kidney failure (dialysis, creatinin \> 350µmol/l * Pregnancy * Time for transfer to the angioplasty room evaluated by coordinating doctor as more than 90 minutes * Subject participating in another trial * Subject with high hemorrhagic risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TIMI 2-3 flow on first coronary artery opacification | start of coronarography |
Secondary
| Measure | Time frame |
|---|---|
| TIMI 3, TIMI 2 and TIMI 1-0 flow frequency in responsible artery before and after angioplasty | before and after angioplasty |
| left ventricular ejection fraction value | during angioplasty |
| Protocol déviations of Tirofiban administration (no bolus, bolus decreasing or increasing of +/- 10% from expected value, dose perfusion decreasing or increasing of 1 ml/h from expected value, time perfusion > 24h or < 18h | During tirofiban administration |
| reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%) | after angioplasty |
| Outcome of following Serious Adverse Events: anginal recurrence, infarct recurrence, urgent revascularization, serious heart failure and hospital mortality | During hospitalization |
| CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty) | during 24h after angioplasty |
Countries
France
Outcome results
None listed