Clinical trial NCT00538317: GPIIbIIIa Inhibitors in the RESCUe and RESURCOR Networks at the Acute Myocardial Infarction
Official title: Comparison of Administration of Tirofiban in the Ambulance or in the Cathlab in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction,
GPIIbIIIa inhibitors,
primary angioplasty,
tirofiban
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: TIMI 2-3 flow on first coronary artery opacification
timeFrame: start of coronarography
Secondary outcomes:
measure: 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
timeFrame: During tirofiban administration
measure: TIMI 3, TIMI 2 and TIMI 1-0 flow frequency in responsible artery before and after angioplasty
timeFrame: before and after angioplasty
measure: left ventricular ejection fraction value
timeFrame: during angioplasty
measure: CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty)
timeFrame: during 24h after angioplasty
measure: reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%)
timeFrame: after angioplasty
measure: Outcome of following Serious Adverse Events: anginal recurrence, infarct recurrence, urgent revascularization, serious heart failure and hospital mortality
timeFrame: During hospitalization
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Eric Bonnefoy-Cudraz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Khoury C, Dubien PY, Mercier C, Belle L, Debaty G, Capel O, Perret T, Savary D, Serre P, Bonnefoy E; AGIR-2 Investigators. Prehospital high-dose tirofiban in patients undergoing primary percutaneous intervention. The AGIR-2 study. Arch Cardiovasc Dis. 2010 May;103(5):285-92. doi: 10.1016/j.acvd.2010.04.005. Epub 2010 Jun 17.