Myocardial InfarctionPhase 4NCT01080638
Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.
A Phase 4 study testing glycoprotein IIb/IIIa inhibitor (abciximab) in people with Myocardial Infarction and Angioplasty, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Intracoronary bolus Abciximab single is non-inferior to intravenous and continuous 12- hours infusion in the size reduction of infarction on cardiac magnetic resonance in Non-ST elevation Myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, Angioplasty
- What is being tested?
- glycoprotein IIb/IIIa inhibitor (abciximab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2009to Dec 2012
- 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
- non-ST segment elevation acute myocardial infarction
- within 48 hours presence of chest pain
- Troponin-T or I positive before CAG
- First myocardial infarction
- will be performed coronary angioplasty
Who cannot join
- under 18 years of age,80 years or older
- Bleeding tendency
- History of major surgery within 4 weeks
- Major stroke within 2 years
- Thrombocytopenia (<120,000 / uL)
- Cardiogenic shock
Show all 10Show fewer
- Known allergy to aspirin, heparin, or abciximab
- Contraindication of MRI at study entry (implanted pacemakers, defibrillators, intracranial metallic implants etc)
- Chronic atrial fibrillation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
Seoul
About this study
Intracoronary bolus Abciximab single is non-inferior to intravenous and continuous 12- hours infusion in the size reduction of infarction on cardiac magnetic resonance in Non-ST elevation Myocardial infarction.
- Conditions
- Myocardial Infarction, Angioplasty
- Being tested
- glycoprotein IIb/IIIa inhibitor (abciximab)
- Keywords
- abciximab, Myocardial Infarction, angioplasty, Platelet
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycoprotein IIb/IIIa inhibitor (abciximab)Drug
patients intracoronary bolus only group and intravenous bolus and 12-hours continuous infusion group bolus:0.25mg/kg body weight,continus 12hrs-0.125ug/kg per minute(maximum: 10ug/min)
| Study group | Role | What they receive |
|---|---|---|
| Abciximab IC bolus | Experimental | After CAG, For patients with undergoing percutaneous coronary intervention, intracoronary only or intravenous bolus abciximab(0.25mg/kg body weight) administration with intravenous bolus group has subsequent 12-hours continuous infusion at a dose 0.125ug/kg per minute (maximum: 10ug/min) Receives: Drug: glycoprotein IIb/IIIa inhibitor (abciximab) |
| Abciximab IV bolus and 12hr continuous | Active comparator | Not described Receives: Drug: glycoprotein IIb/IIIa inhibitor (abciximab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
In cardiac MRI- infarct size (total late enhancement volume at day 3-7)
MRI: magnetic resonance image
Measured: day 3~7 after percutaneous coronary intervention
Secondary outcomes (5)
in-hospital and after 1-months:the major adverse cardiovascular events : death, myocardial infarction, hospitalization for heart failure, myocardial ischemia, etc.
Measured: 1 month
b. major bleeding : Hemoglobin 4 or more reduction, 2-unit If you need more than two RBC transfusions, intracranial or retroperitoneal bleeding, urgent operation for bleeding complication.
RBC: red blood cell
Measured: 1 month
TIMI III flow count /myocardial blush score after PCI
TIMI: thrombolysis in myocardial infarction PCI: percutaneous coronary intervention
Measured: 1 day
At cardiac MRI : LV ejection fraction,LV end-systolic volume,LV end diastolic volume,regional wall motion score index
LV: left ventricle
Measured: 1 week
Discharge, 1- month after comparing NT-proBNP
NT-proBNP : N-terminal pro-B-Type natriuretic peptide
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: The study was terminated early due to a shortage of research and analytical personnel, which prevented the completion of the study as planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Hyo-Soo Kim, Seoul National University Hospital
- Investigators
- Hyun-Jae Kang, Prof, Study director, Assistant professor, Cardiology, Department of internal medicine,Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080638
- Sponsor's protocol ID
- H-0906-046-283
- Status last verified
- Apr 2026
- First submitted
- 16 Feb 2010
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT01080638
- Acronym / sponsor ID
- H-0906-046-283
- Conditions
- Myocardial Infarction, Angioplasty
- Keywords
- abciximab, Myocardial Infarction, angioplasty, Platelet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to a shortage of research and analytical personnel, which prevented the completion of the study as planned
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- Aug 2009 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Mar 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.
Intracoronary bolus Abciximab single is non-inferior to intravenous and continuous 12- hours infusion in the size reduction of infarction on cardiac magnetic resonance in Non-ST elevation Myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abciximab IC bolus | Experimental | Drug: glycoprotein IIb/IIIa inhibitor (abciximab)After CAG, For patients with undergoing percutaneous coronary intervention, intracoronary only or intravenous bolus abciximab(0.25mg/kg body weight) administration with intravenous bolus group has subsequent 12-hours continuous infusion at a dose 0.125ug/kg per minute (maximum: 10ug/min) |
| Abciximab IV bolus and 12hr continuous | Active comparator | Drug: glycoprotein IIb/IIIa inhibitor (abciximab) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- non-ST segment elevation acute myocardial infarction
- within 48 hours presence of chest pain
- Troponin-T or I positive before CAG
- First myocardial infarction
- will be performed coronary angioplasty
Key exclusion criteria (10 listed)
- under 18 years of age,80 years or older
- Bleeding tendency
- History of major surgery within 4 weeks
- Major stroke within 2 years
- Thrombocytopenia (<120,000 / uL)
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 |
|---|---|---|
| glycoprotein IIb/IIIa inhibitor (abciximab)patients intracoronary bolus only group and intravenous bolus and 12-hours continuous infusion group bolus:0.25mg/kg body weight,continus 12hrs-0.125ug/kg per minute(maximum: 10ug/min) | Drug | Abciximab IC bolus, Abciximab IV bolus and 12hr continuous |
Primary outcome
In cardiac MRI- infarct size (total late enhancement volume at day 3-7)
Time frame: day 3~7 after percutaneous coronary intervention
MRI: magnetic resonance image
5 secondary outcomes
in-hospital and after 1-months:the major adverse cardiovascular events : death, myocardial infarction, hospitalization for heart failure, myocardial ischemia, etc.
Time frame: 1 month
b. major bleeding : Hemoglobin 4 or more reduction, 2-unit If you need more than two RBC transfusions, intracranial or retroperitoneal bleeding, urgent operation for bleeding complication.
Time frame: 1 month
TIMI III flow count /myocardial blush score after PCI
Time frame: 1 day
At cardiac MRI : LV ejection fraction,LV end-systolic volume,LV end diastolic volume,regional wall motion score index
Time frame: 1 week
Discharge, 1- month after comparing NT-proBNP
Time frame: 1 month
Results and safety
The study was stopped early (reason given: The study was terminated early due to a shortage of research and analytical personnel, which prevented the completion of the study as planned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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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.
Hyun-Jae Kang, Prof study director
Assistant professor, Cardiology, Department of internal medicine,Seoul National University Hospital
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 glycoprotein IIb/IIIa inhibitor (abciximab) in people with Myocardial Infarction and Angioplasty, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 27 Apr 2026. 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 South Korea. 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 was stopped early (reason given: The study was terminated early due to a shortage of research and analytical personnel, which prevented the completion of the study as planned). Results are not available in the source record.
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?
In cardiac MRI- infarct size (total late enhancement volume at day 3-7) (time frame: day 3~7 after percutaneous coronary intervention). 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 27 Apr 2026.