Acute Myocardial InfarctionPhase 3NCT01109134
Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients
A Phase 3 study testing tirofiban intracoronary bolus-only and tirofiban intravenous bolus plus infusion in people with Acute Myocardial Infarction, run by Kosuyolu Heart Hospital.
Trial summary
The aim of this randomized trial is to compare the efficacy of high dose tirofiban administered as either an intracoronary bolus alone or as an intravenous bolus followed by a maintenance infusion with respect to microvascular perfusion and long term left ventricular infarct size, volumes and function. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- tirofiban intracoronary bolus-only and tirofiban intravenous bolus plus infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Aug 2009
- Phase
- Phase 3
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Typical ongoing ischemic chest pain for longer than 30 minutes
- ST segment elevation of 0,1 mV or greater in at least two contiguous leads or a new left bundle branch block on the initial ECG.
Who cannot join
- Cardiogenic shock and / or clinical instability
- previous STEMI
- Malignant life threatening diseases
- Presence of an additional lesion causing more than 50% narrowing distal to the culprit lesion
- Contraindications to aspirin, clopidogrel, or heparin
- inability to give informed consent.
About this study
Official title: Prospective Randomized Controlled Clinical Study to Compare Tirofiban Intracoronary Bolus-Only vs Intravenous Bolus Plus Infusion in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
The aim of this randomized trial is to compare the efficacy of high dose tirofiban administered as either an intracoronary bolus alone or as an intravenous bolus followed by a maintenance infusion with respect to microvascular perfusion and long term left ventricular infarct size, volumes and function.
Read the detailed description
Primary percutaneous coronary intervention (PCI) is currently the treatment of choice for patients with acute ST elevation myocardial infarction (STEMI). Nevertheless, despite restoration of normal epicardial flow, myocardial perfusion remains impaired in approximately half of patients and is associated with a poor prognosis. A variety of invasive and non-invasive techniques have been proposed to evaluate microvascular perfusion and several invasive hemodynamic measures have been closely associated with microvascular damage.In order to improve microvascular perfusion after primary PCI, a variety of treatment strategies have been developed, such as adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPIs). Although current ACC/AHA guidelines recommend that small molecule GPIs should be administered as a bolus followed by 18 hours of continuous infusion, changes in clinical practice may obviate the need for a maintenance infusion in current practice.
We hypothesized that when tirofiban is administered via intracoronary route, a bolus-only strategy may even be superior to intravenous bolus plus infusion strategy in maintaining myocardial perfusion. In order to evaluate microvascular function, we used a guidewire tipped with pressure and temperature sensors and measured the coronary hemodynamic parameters, as the index of microvascular resistance and coronary flow reserve, measures which have been closely associated with microvascular damage. In order to increase the predictive value of these indices, we performed these measurements four to five days after MI, because it has been shown that the extent of microvascular dysfunction changes, particularly within first 48 hours after reperfusion and stabilizes between 2 days and 1 week after perfusion
- Conditions
- Acute Myocardial Infarction
- Being tested
- tirofiban intracoronary bolus-only, tirofiban intravenous bolus plus infusion
- Keywords
- primary angioplasty, tirofiban, microcirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tirofiban intracoronary bolus-onlyDrug
Also called Aggrastat
administer tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion
tirofiban intravenous bolus plus infusionDrug
Also called Aggrastat
administer tirofiban bolus intravenously and maintain infusion for up to 18 hours
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban intracoronary bolus-only | Experimental | Tirofiban bolus administered via intracoronary route at the time of primary PCI with no additional peri/postprocedural maintenance infusion Receives: Drug: tirofiban intracoronary bolus-only |
| Tirofiban intravenous bolus+infusion | Active comparator | Tirofiban bolus administered intravenously before PCI, followed by periprocedural maintenance infusion Receives: Drug: tirofiban intravenous bolus plus infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indices of microvascular perfusion
Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve
Measured: Post-PCI day 4 to 5
Secondary outcomes (6)
ST segment resolution
Measured: post-PCI 90. minute
corrected TIMI frame count
Measured: immediately after PCI, post-PCI day 4 to 5
Myocardial Blush Grade
Measured: immediately after PCI, post-PCI day 4 to 5
Scintigraphic infarct size
Left ventricular infarct size by SPECT
Measured: 6th month
Changes in left ventricular volume
Measured with echocardiography by using modified Simpson's method
Measured: Post-PCI day 3- 6th month
Composite of major adverse cardiovascular events
composite of reinfarction, target vessel revascularization and death.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startSep 2008
- Primary completionFeb 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kosuyolu Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Society of Cardiac Health Protection
- Investigators
- Cevat Kırma, Assoc.Prof, Study chair, Kosuyolu Heart and Research HospitalAyhan Erkol, M.D, Principal investigator, Kosuyolu Heart and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109134
- Sponsor's protocol ID
- 33
- Status last verified
- Mar 2010
- First submitted
- 21 Apr 2010
- Last updated
- 22 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Clinical Study to Compare Tirofiban Intracoronary Bolus-Only vs Intravenous Bolus Plus Infusion in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01109134
- Acronym / sponsor ID
- 33
- Conditions
- Acute Myocardial Infarction
- Keywords
- primary angioplasty, tirofiban, microcirculation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Kosuyolu Heart HospitalUniversity, hospital or other
- Collaborators
- The Society of Cardiac Health Protection
- Study start
- Sep 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Apr 2010 (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.
The aim of this randomized trial is to compare the efficacy of high dose tirofiban administered as either an intracoronary bolus alone or as an intravenous bolus followed by a maintenance infusion with respect to microvascular perfusion and long term left ventricular infarct size, volumes and function.
Detailed description
Primary percutaneous coronary intervention (PCI) is currently the treatment of choice for patients with acute ST elevation myocardial infarction (STEMI). Nevertheless, despite restoration of normal epicardial flow, myocardial perfusion remains impaired in approximately half of patients and is associated with a poor prognosis. A variety of invasive and non-invasive techniques have been proposed to evaluate microvascular perfusion and several invasive hemodynamic measures have been closely associated with microvascular damage.In order to improve microvascular perfusion after primary PCI, a variety of treatment strategies have been developed, such as adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPIs). Although current ACC/AHA guidelines recommend that small molecule GPIs should be administered as a bolus followed by 18 hours of continuous infusion, changes in clinical practice may obviate the need for a maintenance infusion in current practice.
We hypothesized that when tirofiban is administered via intracoronary route, a bolus-only strategy may even be superior to intravenous bolus plus infusion strategy in maintaining myocardial perfusion. In order to evaluate microvascular function, we used a guidewire tipped with pressure and temperature sensors and measured the coronary hemodynamic parameters, as the index of microvascular resistance and coronary flow reserve, measures which have been closely associated with microvascular damage. In order to increase the predictive value of these indices, we performed these measurements four to five days after MI, because it has been shown that the extent of microvascular dysfunction changes, particularly within first 48 hours after reperfusion and stabilizes between 2 days and 1 week after perfusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban intracoronary bolus-only | Experimental | Drug: tirofiban intracoronary bolus-onlyTirofiban bolus administered via intracoronary route at the time of primary PCI with no additional peri/postprocedural maintenance infusion |
| Tirofiban intravenous bolus+infusion | Active comparator | Drug: tirofiban intravenous bolus plus infusionTirofiban bolus administered intravenously before PCI, followed by periprocedural maintenance infusion |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Typical ongoing ischemic chest pain for longer than 30 minutes
- ST segment elevation of 0,1 mV or greater in at least two contiguous leads or a new left bundle branch block on the initial ECG.
Key exclusion criteria (6 listed)
- Cardiogenic shock and / or clinical instability
- previous STEMI
- Malignant life threatening diseases
- Presence of an additional lesion causing more than 50% narrowing distal to the culprit lesion
- Contraindications to aspirin, clopidogrel, or heparin
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 |
|---|---|---|
| tirofiban intracoronary bolus-onlyAlso: Aggrastatadminister tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion | Drug | Tirofiban intracoronary bolus-only |
| tirofiban intravenous bolus plus infusionAlso: Aggrastatadminister tirofiban bolus intravenously and maintain infusion for up to 18 hours | Drug | Tirofiban intravenous bolus+infusion |
Primary outcome
Indices of microvascular perfusion
Time frame: Post-PCI day 4 to 5
Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve
6 secondary outcomes
ST segment resolution
Time frame: post-PCI 90. minute
corrected TIMI frame count
Time frame: immediately after PCI, post-PCI day 4 to 5
Myocardial Blush Grade
Time frame: immediately after PCI, post-PCI day 4 to 5
Scintigraphic infarct size
Time frame: 6th month
Changes in left ventricular volume
Time frame: Post-PCI day 3- 6th month
Composite of major adverse cardiovascular events
Time frame: 6 month
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 22 Apr 2010.
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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.
Cevat Kırma, Assoc.Prof study chair
Kosuyolu Heart and Research Hospital
Ayhan Erkol, M.D principal investigator
Kosuyolu Heart and Research Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tirofiban intracoronary bolus-only and tirofiban intravenous bolus plus infusion in people with Acute Myocardial Infarction, run by Kosuyolu Heart Hospital.
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 2 inclusion and 6 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 22 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Indices of microvascular perfusion (time frame: Post-PCI day 4 to 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2010.