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OpenTrials
Completed

NCT Number: NCT00538317

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

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospices Civils de Lyon

Lyon, 6900, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tirofiban

Drug

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

Other names: agrastat

Primary outcomes

  1. TIMI 2-3 flow on first coronary artery opacification

    Time frame: start of coronarography

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: AGIR2

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 2, 2007
Registry last updated
Nov 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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