Acute Myocardial InfarctionPhase 4AGIR2NCT00538317
GPIIbIIIa Inhibitors in the RESCUe and RESURCOR Networks at the Acute Myocardial Infarction
A Phase 4 study testing tirofiban in people with Acute Myocardial Infarction, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- tirofiban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2007to Nov 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Administration of Tirofiban in the Ambulance or in the Cathlab in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty
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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- tirofiban
- Keywords
- Acute myocardial infarction,, GPIIbIIIa inhibitors,, primary angioplasty,, tirofiban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tirofibanDrug
Also called agrastat
bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min
tirofibanDrug
Also called agrastat
bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | tirofiban bolus + perfusion started at the site of caring Receives: Drug: tirofiban |
| 2 | Active comparator | tirofiban bolus + perfusion started at the beginning of coronarography (usual use of tirofiban) Receives: Drug: tirofiban |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIMI 2-3 flow on first coronary artery opacification
Measured: 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
Measured: During tirofiban administration
TIMI 3, TIMI 2 and TIMI 1-0 flow frequency in responsible artery before and after angioplasty
Measured: before and after angioplasty
left ventricular ejection fraction value
Measured: during angioplasty
CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty)
Measured: during 24h after angioplasty
reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%)
Measured: after angioplasty
Outcome of following Serious Adverse Events: anginal recurrence, infarct recurrence, urgent revascularization, serious heart failure and hospital mortality
Measured: During hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startJul 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Eric Bonnefoy-Cudraz, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538317
- Sponsor's protocol ID
- 2006-452
- Acronym
- AGIR2
- Status last verified
- Nov 2008
- First submitted
- 1 Oct 2007
- Last updated
- 24 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20619238
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Administration of Tirofiban in the Ambulance or in the Cathlab in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty
- ClinicalTrials.gov ID
- NCT00538317
- Acronym / sponsor ID
- AGIR2 / 2006-452
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction,, GPIIbIIIa inhibitors,, primary angioplasty,, tirofiban
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tirofibantirofiban bolus + perfusion started at the site of caring |
| 2 | Active comparator | Drug: tirofibantirofiban bolus + perfusion started at the beginning of coronarography (usual use of tirofiban) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tirofibanAlso: agrastatbolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min | Drug | 1 |
| tirofibanAlso: agrastatbolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min | Drug | 2 |
Primary outcome
TIMI 2-3 flow on first coronary artery opacification
Time frame: start of coronarography
6 secondary outcomes
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
TIMI 3, TIMI 2 and TIMI 1-0 flow frequency in responsible artery before and after angioplasty
Time frame: before and after angioplasty
left ventricular ejection fraction value
Time frame: during angioplasty
CPK and troponin values (before and after angioplasty, peak and 24h after angioplasty)
Time frame: during 24h after angioplasty
reduction of ST segment elevation (considered as resoluted if amplitude decreasing > 70%)
Time frame: after angioplasty
Outcome of following Serious Adverse Events: anginal recurrence, infarct recurrence, urgent revascularization, serious heart failure and hospital mortality
Time frame: During hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2008.
- Derived from this study: PubMed 20619238El 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Bonnefoy-Cudraz, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tirofiban in people with Acute Myocardial Infarction, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIMI 2-3 flow on first coronary artery opacification (time frame: start of coronarography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00538317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2008.