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AGIR2: GPIIbIIIa Inhibitors in the RESCUe and RESURCOR Networks at the Acute Myocardial Infarction

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT00538317
Collaborator
(none)
320
Enrollment
1
Location
2
Arms
16.1
Duration (Months)
19.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

tirofiban bolus + perfusion started at the site of caring

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

    		•
    Active Comparator: 2

    tirofiban bolus + perfusion started at the beginning of coronarography (usual use of tirofiban)

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. TIMI 2-3 flow on first coronary artery opacification [start of coronarography]

    Secondary Outcome Measures

    1. 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]

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

    3. left ventricular ejection fraction value [during angioplasty]

    4. CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty) [during 24h after angioplasty]

    5. reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%) [after angioplasty]

    6. Outcome of following Serious Adverse Events: anginal recurrence, infarct recurrence, urgent revascularization, serious heart failure and hospital mortality [During hospitalization]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospices Civils de Lyon Lyon France 6900

    Sponsors and Collaborators

    • Hospices Civils de Lyon

    Investigators

    • Principal Investigator: Eric Bonnefoy-Cudraz, MD, Hospices Civils de Lyon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00538317
    Other Study ID Numbers:
    • 2006-452
    First Posted:
    Oct 2, 2007
    Last Update Posted:
    Nov 24, 2008
    Last Verified:
    Nov 1, 2008
    Keywords provided by , ,
    Acute myocardial infarction,
    GPIIbIIIa inhibitors,
    primary angioplasty,
    tirofiban
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction
    Tirofiban

    Study Results

    No Results Posted as of Nov 24, 2008