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

Hospices Civils de Lyon320 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

320

Conditions

Acute Myocardial Infarction

Interventions

tirofibanDRUG

bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min

tirofibanDRUG

bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospices Civils de Lyon

Lyon, France

Outcomes

Primary Outcomes

TIMI 2-3 flow on first coronary artery opacification

Time frame: start of coronarography

Secondary Outcomes

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

Time frame: During tirofiban administration

TIMI 3, TIMI 2 and TIMI 1-0 flow frequency in responsible artery before and after angioplasty

Time frame: before and after angioplasty

left ventricular ejection fraction value

Time frame: during angioplasty

CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty)

Time frame: during 24h after angioplasty

reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%)

Time frame: after angioplasty

Outcome of following Serious Adverse Events: anginal recurrence, infarct recurrence, urgent revascularization, serious heart failure and hospital mortality

Time frame: During hospitalization

Data from ClinicalTrials.gov

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