Acute Myocardial InfarctionPhase 4NCT00611169
The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction
A Phase 4 study testing tirofiban in people with Acute Myocardial Infarction, run by Samsung Medical Center.
Trial summary
The purpose of this study to investigate whether the administration of high-dose tirofiban before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- tirofiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Aug 2007
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
- ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage
Who cannot join
- hemodynamic instability
- history of MI
- old age > 80years
- Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
About this study
Official title: The Effects of Facilitated Percutaeous Coronary Intervention Compared to Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Acute Myocardial Infarction
The purpose of this study to investigate whether the administration of high-dose tirofiban before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced magnetic resonance imaging.
- Conditions
- Acute Myocardial Infarction
- Being tested
- tirofiban
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary, tirofiban, Magnetic Resonance Imaging, Myocardial Infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tirofibanDrug
tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aspirin, clopidogrel, unfractionated heparin plus tirofiban infusion at high bolus dose Receives: Drug: tirofiban |
| 2 | No intervention | Aspirin, clopidogrel, unfractionated heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size and its transmural extent using MRI
Measured: within the first 30 days after index procedure
Secondary outcomes (1)
pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography
Measured: at 6 month after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startJan 2006
- Primary completionFeb 2007
- Study completionAug 2007
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.
- More trials run by Samsung Medical CenterThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Hyeon-Cheol Gwon, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611169
- Sponsor's protocol ID
- 2005-09-007-001
- Status last verified
- Aug 2007
- First submitted
- 27 Jan 2008
- Last updated
- 8 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Facilitated Percutaeous Coronary Intervention Compared to Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00611169
- Acronym / sponsor ID
- 2005-09-007-001
- Conditions
- Acute Myocardial Infarction
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary, tirofiban, Magnetic Resonance Imaging, Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 8 Feb 2008 (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 purpose of this study to investigate whether the administration of high-dose tirofiban before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced magnetic resonance imaging.
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: tirofibanAspirin, clopidogrel, unfractionated heparin plus tirofiban infusion at high bolus dose |
| 2 | No intervention | –Aspirin, clopidogrel, unfractionated heparin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
- ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage
Key exclusion criteria (4 listed)
- hemodynamic instability
- history of MI
- old age > 80years
- Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
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 |
|---|---|---|
| tirofibantirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours) | Drug | 1 |
Primary outcome
Infarct size and its transmural extent using MRI
Time frame: within the first 30 days after index procedure
1 secondary outcome
pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography
Time frame: at 6 month after index procedure
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 8 Feb 2008.
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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.
Hyeon-Cheol Gwon, MD, PhD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tirofiban in people with Acute Myocardial Infarction, run by Samsung Medical Center.
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 4 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 8 Feb 2008. 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 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?
Infarct size and its transmural extent using MRI (time frame: within the first 30 days after index procedure). 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 8 Feb 2008.