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

This study has been completed.
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00538317
First received: October 1, 2007
Last updated: November 21, 2008
Last verified: November 2008
History of Changes
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
 Drug: tirofiban
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • TIMI 2-3 flow on first coronary artery opacification [ Time Frame: start of coronarography ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • TIMI 3, TIMI 2 and TIMI 1-0 flow frequency in responsible artery before and after angioplasty [ Time Frame: before and after angioplasty ] [ Designated as safety issue: No ]
  • left ventricular ejection fraction value [ Time Frame: during angioplasty ] [ Designated as safety issue: No ]
  • CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty) [ Time Frame: during 24h after angioplasty ] [ Designated as safety issue: No ]
  • reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%) [ Time Frame: after angioplasty ] [ Designated as safety issue: No ]
  • Outcome of following Serious Adverse Events: anginal recurrence, infarct recurrence, urgent revascularization, serious heart failure and hospital mortality [ Time Frame: During hospitalization ] [ Designated as safety issue: No ]

Enrollment: 320
Study Start Date: July 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: agrastat

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538317

Locations
France
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
  More Information

No publications provided by Hospices Civils de Lyon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eric BONNEFOY-CUDRAZ, MD, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00538317     History of Changes
Other Study ID Numbers: 2006-452
Study First Received: October 1, 2007
Last Updated: November 21, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Acute myocardial infarction,
GPIIbIIIa inhibitors,
primary angioplasty,
tirofiban

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Tirofiban
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013