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

Phase 4

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: tirofiban

• Registration Number: NCT00538317
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-10-01
• Study First Submitted QC: 2007-10-01
• Study First Posted: 2007-10-02
• Status Verified: 2008-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Last Update Submitted: 2008-11-21
• Last Update Posted: 2008-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tirofiban	tirofiban bolus + perfusion started at the site of caring
2	tirofiban	tirofiban bolus + perfusion started at the beginning of coronarography (usual use of tirofiban)

Primary Outcome Measures

Name	Time	Method
TIMI 2-3 flow on first coronary artery opacification	start of coronarography

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France