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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
tirofiban
tirofiban
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction,, GPIIbIIIa inhibitors,, primary angioplasty,, tirofiban

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

tirofiban bolus + perfusion started at the site of caring

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

Outcomes

Primary Outcome Measures

TIMI 2-3 flow on first coronary artery opacification

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
TIMI 3, TIMI 2 and TIMI 1-0 flow frequency in responsible artery before and after angioplasty
left ventricular ejection fraction value
CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty)
reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%)
Outcome of following Serious Adverse Events: anginal recurrence, infarct recurrence, urgent revascularization, serious heart failure and hospital mortality

Full Information

First Posted
October 1, 2007
Last Updated
November 21, 2008
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00538317
Brief Title
GPIIbIIIa Inhibitors in the RESCUe and RESURCOR Networks at the Acute Myocardial Infarction
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction,, GPIIbIIIa inhibitors,, primary angioplasty,, tirofiban

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
tirofiban bolus + perfusion started at the site of caring
Arm Title
2
Arm Type
Active Comparator
Arm Description
tirofiban bolus + perfusion started at the beginning of coronarography (usual use of tirofiban)
Intervention Type
Drug
Intervention Name(s)
tirofiban
Other Intervention Name(s)
agrastat
Intervention Description
bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min
Intervention Type
Drug
Intervention Name(s)
tirofiban
Other Intervention Name(s)
agrastat
Intervention Description
bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min
Primary Outcome Measure Information:
Title
TIMI 2-3 flow on first coronary artery opacification
Time Frame
start of coronarography
Secondary Outcome Measure Information:
Title
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
Title
TIMI 3, TIMI 2 and TIMI 1-0 flow frequency in responsible artery before and after angioplasty
Time Frame
before and after angioplasty
Title
left ventricular ejection fraction value
Time Frame
during angioplasty
Title
CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty)
Time Frame
during 24h after angioplasty
Title
reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%)
Time Frame
after angioplasty
Title
Outcome of following Serious Adverse Events: anginal recurrence, infarct recurrence, urgent revascularization, serious heart failure and hospital mortality
Time Frame
During hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Bonnefoy-Cudraz, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
6900
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20619238
Citation
El Khoury C, Dubien PY, Mercier C, Belle L, Debaty G, Capel O, Perret T, Savary D, Serre P, Bonnefoy E; AGIR-2 Investigators. Prehospital high-dose tirofiban in patients undergoing primary percutaneous intervention. The AGIR-2 study. Arch Cardiovasc Dis. 2010 May;103(5):285-92. doi: 10.1016/j.acvd.2010.04.005. Epub 2010 Jun 17.
Results Reference
derived

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

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