GPIIbIIIa Inhibitors in the RESCUe and RESURCOR Networks at the Acute Myocardial Infarction

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Administration of Tirofiban in the Ambulance or in the Cathlab in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: tirofiban
* Drug: tirofiban


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>tirofiban bolus + perfusion started at the site of caring | Drug: tirofiban<br>* bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min<br>* Other names: agrastat;|
| Active Comparator: 2<br>tirofiban bolus + perfusion started at the beginning of coronarography (usual use of tirofiban) | Drug: tirofiban<br>* bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min<br>* Other names: agrastat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIMI 2-3 flow on first coronary artery opacification |  | start of coronarography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty) |  | during 24h after angioplasty | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myocardial infarction,, GPIIbIIIa inhibitors,, primary angioplasty,, tirofiban