Acute Coronary SyndromeNCT00760786
Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque
A study testing Intensive lipid lowering plus Omega3-fatty acid and Moderate lipid lowering plus Omega3-fatty acid in people with Acute Coronary Syndrome, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether intensive lipid lowering and Omega-3 fatty acid are effective in the treatment of coronary atherosclerotic plaque. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Intensive lipid lowering plus Omega3-fatty acid and Moderate lipid lowering plus Omega3-fatty acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2008to Feb 2010
- Phase
- Interventional
- 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
- Acute coronary syndrome within 48 hours of symptom onset
- Have de novo non-culprit coronary artery stenosis 20% to 70% by visual estimation
Who cannot join
- Cardiogenic shock
- ST segment elevation myocardial infarction within 1 week
- Hematologic disorder: neutropenia (neutrophil<3000/mm3), thrombocytopenia (platelet<100,000/mm3)
- Liver enzyme elevation: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
- Impaired renal function with serum creatinine > 2mg/dL
- Bleeding diathesis or history of coagulopathy
- Pregnancy
- Hypersensitivity to heparin, dye, aspirin, clopidogrel, statin, or fish
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Cardiac and Vascular Center; Samsung Medical Center
Seoul, 135-710
Hyeon-Cheol Gwon, Professor, 82234103419, hc.gwon@samsung.com
About this study
Official title: Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque: Serial Virtual Histology Intravascular Ultrasound Analysis
The purpose of this study is to determine whether intensive lipid lowering and Omega-3 fatty acid are effective in the treatment of coronary atherosclerotic plaque.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Intensive lipid lowering plus Omega3-fatty acid, Moderate lipid lowering plus Omega3-fatty acid, Intensive lipid lowering plus placebo, Moderate lipid lowering plus placebo
- Keywords
- IVUS-VH, Plaque characterization, Omega3-fatty acid, Atorvastatin
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive lipid lowering plus Omega3-fatty acidDrug
Atorvastatin 40mg qd plus Omega3-fatty acid 2.0mg qd
Moderate lipid lowering plus Omega3-fatty acidDrug
atorvastatin 10mg qd plus Omega3-fatty acid 2.0mg qd
Intensive lipid lowering plus placeboDrug
atorvastatin 40mg qd
Moderate lipid lowering plus placeboDrug
atorvastatin 10mg qd
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Intensive lipid lowering plus Omega3-fatty acid Receives: Drug: Intensive lipid lowering plus Omega3-fatty acid |
| 2 | Active comparator | Moderate lipid lowering plus Omega3-fatty acid Receives: Drug: Moderate lipid lowering plus Omega3-fatty acid |
| 3 | Active comparator | Intensive lipid lowering plus placebo Receives: Drug: Intensive lipid lowering plus placebo |
| 4 | Active comparator | Moderate lipid lowering plus placebo Receives: Drug: Moderate lipid lowering plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque stabilization using serial virtual histology intravascular ultrasound analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Joo-Yong Han, Professor, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760786
- Sponsor's protocol ID
- SMC IRB 2007-09-006
- Status last verified
- Sep 2008
- First submitted
- 25 Sep 2008
- Last updated
- 26 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque: Serial Virtual Histology Intravascular Ultrasound Analysis
- ClinicalTrials.gov ID
- NCT00760786
- Acronym / sponsor ID
- SMC IRB 2007-09-006
- Conditions
- Acute Coronary Syndrome
- Keywords
- IVUS-VH, Plaque characterization, Omega3-fatty acid, Atorvastatin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Feb 2010 (estimated)
- First posted
- 26 Sep 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 is to determine whether intensive lipid lowering and Omega-3 fatty acid are effective in the treatment of coronary atherosclerotic plaque.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Intensive lipid lowering plus Omega3-fatty acidIntensive lipid lowering plus Omega3-fatty acid |
| 2 | Active comparator | Drug: Moderate lipid lowering plus Omega3-fatty acidModerate lipid lowering plus Omega3-fatty acid |
| 3 | Active comparator | Drug: Intensive lipid lowering plus placeboIntensive lipid lowering plus placebo |
| 4 | Active comparator | Drug: Moderate lipid lowering plus placeboModerate lipid lowering plus placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute coronary syndrome within 48 hours of symptom onset
- Have de novo non-culprit coronary artery stenosis 20% to 70% by visual estimation
Key exclusion criteria (8 listed)
- Cardiogenic shock
- ST segment elevation myocardial infarction within 1 week
- Hematologic disorder: neutropenia (neutrophil<3000/mm3), thrombocytopenia (platelet<100,000/mm3)
- Liver enzyme elevation: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
- Impaired renal function with serum creatinine > 2mg/dL
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 |
|---|---|---|
| Intensive lipid lowering plus Omega3-fatty acidAtorvastatin 40mg qd plus Omega3-fatty acid 2.0mg qd | Drug | 1 |
| Moderate lipid lowering plus Omega3-fatty acidatorvastatin 10mg qd plus Omega3-fatty acid 2.0mg qd | Drug | 2 |
| Intensive lipid lowering plus placeboatorvastatin 40mg qd | Drug | 3 |
| Moderate lipid lowering plus placeboatorvastatin 10mg qd | Drug | 4 |
Primary outcome
Plaque stabilization using serial virtual histology intravascular ultrasound analysis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 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.
Joo-Yong Han, Professor principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive lipid lowering plus Omega3-fatty acid and Moderate lipid lowering plus Omega3-fatty acid in people with Acute Coronary Syndrome, run by Samsung Medical Center 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 2 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: status not confirmed, as of the sponsor's last update on 26 Sep 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 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyeon-Cheol Gwon, Professor (82-2-3410-3419, hc.gwon@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque stabilization using serial virtual histology intravascular ultrasound analysis (time frame: 1 year). 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 26 Sep 2008.