Coronary Artery DiseasePhase 4NCT00952770
Effect of Statins on the Radial Intima-media Thickness After Transradial Angioplasty
A Phase 4 study testing transradial coronary intervention in people with Coronary Artery Disease, run by Chungnam National University at 1 site in South Korea.
Trial summary
The first event of the atherosclerotic plaque formation is the accumulation of the low density lipoprotein-cholesterol (LDL-cholesterol) in to the intima of the arterial wall. After accumulation of the LDL-cholesterol, the oxidation of the LDL-cholesterol particles and recruitment of monocytes to the intima and media… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- transradial coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2009to Jul 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing coronary intervention via the radial artery
Who cannot join
- Contraindication to statins
- Left ventricular ejection fraction less than 30%
- Recent history of hematologic disease or leukocyte count <3000/mm3 and/or platelet <100 000/mm3
- Hepatic dysfunction with AST or ALT >3 times the upper normal reference limit
- History of renal dysfunction or a serum creatinine level >2.0 mg/dL
- Serious noncardiac comorbid disease with a life expectancy <1 year
- Inability to follow the protocol
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chungnam National University Hospital
Daejeon
Jae-Hyeong Park, MD, PhD, 82-42-280-7167, jaehpark@cnuh.co.kr
About this study
Official title: Effect of Statins on the Progression of the Intima-media Thickness of the Radial Artery After Radial Angioplasty
The first event of the atherosclerotic plaque formation is the accumulation of the low density lipoprotein-cholesterol (LDL-cholesterol) in to the intima of the arterial wall. After accumulation of the LDL-cholesterol, the oxidation of the LDL-cholesterol particles and recruitment of monocytes to the intima and media are the next steps. The thickening of intima-media thickness (IMT) is resulted from these initial events. The IMT can be easily measured by high-resolution ultrasonography in various arteries including carotid, brachial and radial arteries. The increased carotid IMT can be used as a non-invasive independent parameter indicating increased cardiovascular mortality. Some investigators reported increased radial IMT is associated with increased early failure of the radiocephalic arteriovenous fistula in the hemodialysis patients. Moreover, radial IMT is increased in patients underwent radial artery intervention because of denudation injury of the radial artery. Recently, the use of statin can halt the progression of the carotid IMT progression. However, it is unknown that the use of statin can prevent the progression of radial IMT after the transradial coronary intervention. The investigators want to evaluate the effect of statins on the progression of the radial IMT after the transradial intervention.
- Conditions
- Coronary Artery Disease
- Being tested
- transradial coronary intervention
- Keywords
- Coronary artery disease, Coronary intervention, intima-media thickness
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transradial coronary interventionProcedure or surgery
percutaneous coronary intervention with transradial approach
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Group receiving atorvastatin 20mg/day Receives: Procedure: transradial coronary intervention |
| Simvastatin/Ezetimibe | Active comparator | Group receiving simvastatin/ezetimibe 10/10mg Receives: Procedure: transradial coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of IMT between two groups
Measured: 1 month, 6 months
Secondary outcomes (1)
Difference of epicardial fat thickness Difference of cholesterol level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungnam National University
- Sponsor type
- University, hospital or other
- Investigators
- Jae-Hyeong Park, MD, PhD, Principal investigator, Chungnam National University, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952770
- Sponsor's protocol ID
- CNUH-09-07-60
- Status last verified
- Aug 2009
- First submitted
- 4 Aug 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Statins on the Progression of the Intima-media Thickness of the Radial Artery After Radial Angioplasty
- ClinicalTrials.gov ID
- NCT00952770
- Acronym / sponsor ID
- CNUH-09-07-60
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Coronary intervention, intima-media thickness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chungnam National UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (estimated)
- First posted
- 6 Aug 2009 (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 first event of the atherosclerotic plaque formation is the accumulation of the low density lipoprotein-cholesterol (LDL-cholesterol) in to the intima of the arterial wall. After accumulation of the LDL-cholesterol, the oxidation of the LDL-cholesterol particles and recruitment of monocytes to the intima and media are the next steps. The thickening of intima-media thickness (IMT) is resulted from these initial events. The IMT can be easily measured by high-resolution ultrasonography in various arteries including carotid, brachial and radial arteries. The increased carotid IMT can be used as a non-invasive independent parameter indicating increased cardiovascular mortality. Some investigators reported increased radial IMT is associated with increased early failure of the radiocephalic arteriovenous fistula in the hemodialysis patients. Moreover, radial IMT is increased in patients underwent radial artery intervention because of denudation injury of the radial artery. Recently, the use of statin can halt the progression of the carotid IMT progression. However, it is unknown that the use of statin can prevent the progression of radial IMT after the transradial coronary intervention. The investigators want to evaluate the effect of statins on the progression of the radial IMT after the transradial intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Procedure: transradial coronary interventionGroup receiving atorvastatin 20mg/day |
| Simvastatin/Ezetimibe | Active comparator | Procedure: transradial coronary interventionGroup receiving simvastatin/ezetimibe 10/10mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing coronary intervention via the radial artery
Key exclusion criteria (7 listed)
- Contraindication to statins
- Left ventricular ejection fraction less than 30%
- Recent history of hematologic disease or leukocyte count <3000/mm3 and/or platelet <100 000/mm3
- Hepatic dysfunction with AST or ALT >3 times the upper normal reference limit
- History of renal dysfunction or a serum creatinine level >2.0 mg/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 |
|---|---|---|
| transradial coronary interventionpercutaneous coronary intervention with transradial approach | Procedure or surgery | Atorvastatin, Simvastatin/Ezetimibe |
Primary outcome
Difference of IMT between two groups
Time frame: 1 month, 6 months
1 secondary outcome
Difference of epicardial fat thickness Difference of cholesterol level
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
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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.
Jae-Hyeong Park, MD, PhD principal investigator
Chungnam National University, Chungnam 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 transradial coronary intervention in people with Coronary Artery Disease, run by Chungnam National University 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 1 inclusion and 7 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 6 Aug 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae-Hyeong Park, MD, PhD (82-42-280-7167, jaehpark@cnuh.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of IMT between two groups (time frame: 1 month, 6 months). 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 6 Aug 2009.