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

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ClinicalTrials.gov Identifier: NCT00538317
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : November 24, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: tirofiban Phase 4

Study Type : Interventional  (Clinical Trial)
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 : July 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. TIMI 2-3 flow on first coronary artery opacification [ Time Frame: 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 [ Time Frame: During tirofiban administration ]
  2. TIMI 3, TIMI 2 and TIMI 1-0 flow frequency in responsible artery before and after angioplasty [ Time Frame: before and after angioplasty ]
  3. left ventricular ejection fraction value [ Time Frame: during angioplasty ]
  4. CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty) [ Time Frame: during 24h after angioplasty ]
  5. reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%) [ Time Frame: after angioplasty ]
  6. Outcome of following Serious Adverse Events: anginal recurrence, infarct recurrence, urgent revascularization, serious heart failure and hospital mortality [ Time Frame: During hospitalization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: November 24, 2008
Last Verified: November 2008

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
Platelet Aggregation Inhibitors