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

Acute Myocardial Infarction Clinical Trial

— AGIR2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538317
• Other study ID #: 2006-452
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2007
• Last updated: November 21, 2008
• Start date: July 2007
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIMI 2-3 flow on first coronary artery opacification		start of coronarography	No
Secondary	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	No
Secondary	TIMI 3, TIMI 2 and TIMI 1-0 flow frequency in responsible artery before and after angioplasty		before and after angioplasty	No
Secondary	left ventricular ejection fraction value		during angioplasty	No
Secondary	CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty)		during 24h after angioplasty	No
Secondary	reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%)		after angioplasty	No
Secondary	Outcome of following Serious Adverse Events: anginal recurrence, infarct recurrence, urgent revascularization, serious heart failure and hospital mortality		During hospitalization	No