NCT00538317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 24, 2008

Status Verified

November 1, 2008

Enrollment Period

1.3 years

First QC Date

October 1, 2007

Last Update Submit

November 21, 2008

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarction,GPIIbIIIa inhibitors,primary angioplasty,tirofiban

Outcome Measures

Primary Outcomes (1)

  • TIMI 2-3 flow on first coronary artery opacification

    start of coronarography

Secondary Outcomes (6)

  • 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

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

    before and after angioplasty

  • left ventricular ejection fraction value

    during angioplasty

  • CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty)

    during 24h after angioplasty

  • reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%)

    after angioplasty

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

tirofiban bolus + perfusion started at the site of caring

Drug: tirofiban

2

ACTIVE COMPARATOR

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

Drug: tirofiban

Interventions

tirofibanDRUG

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

Also known as: agrastat
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 6900, France

Location

Related Publications (1)

  • 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.

    PMID: 20619238DERIVED

MeSH Terms

Interventions

Tirofiban

Intervention Hierarchy (Ancestors)

TyrosineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Eric Bonnefoy-Cudraz, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 2, 2007

Study Start

July 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

November 24, 2008

Record last verified: 2008-11

Locations

FR(1)