Coronary Artery Occlusive DiseaseNCT01872845
A Trial Comparing the Effect of Pravastatin and Rosuvastatin on Atherosclerosis Progression Measured by Carotid Intima Media Thickness in Patients With Coronary Artery Disease After Biolimus Eluting Stent (Nobori®) Implantation: CPR IMT
A study testing Pravastatin 40mg and Rosuvastatin in people with Coronary Artery Occlusive Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Current consensus papers recommend statin medication to reduce Low density lipoprotein (LDL) cholesterol level less than 100mg/dL (optional 70mg/dL) in patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery Occlusive Disease
- What is being tested?
- Pravastatin 40mg and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 671 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jun 2013to 25 May 2017
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 20 years old
- Patients with coronary artery disease who are candidate for coronary revascularization with DES implantation.
- Significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis)
- Patients eligible for statin treatment (initial LDL cholesterol >70mg/dL or patients taking lipid-lowering agent)
Who cannot join
- Severe hepatic dysfunction (3 times normal reference values)
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Current consensus papers recommend statin medication to reduce Low density lipoprotein (LDL) cholesterol level less than 100mg/dL (optional 70mg/dL) in patients with coronary artery disease. However, there is lack of solid evidence whether a specific kind of statin have the superiority against other statins in clinical outcomes. Furthermore, recent data have showed that several kinds of statin could have an adverse effect on glucose metabolism and increase the risk of development of diabetes. Carotid Intimamedia thickness (CIMT) is a surrogate marker of atherosclerosis to predict long term cardiovascular outcomes in not only general population but also patients with established coronary artery disease. Consequently, we will evaluate the efficacy of high dose of pravastatin on CIMT, comparing with moderate dose of rosuvastatin in patients with established coronary artery disease. Additionally, we will assess the clinical outcomes of pravastatin after percutaneous coronary intervention as well as adverse outcomes including insulin resistance and new onset diabetes compared with rosuvastatin. Our main hypothesis is that pravastatin 40mg would be non-inferior to rosuvastatin 20mg regarding CIMT at 1 year follow up.
- Conditions
- Coronary Artery Occlusive Disease
- Being tested
- Pravastatin 40mg, Rosuvastatin
- Keywords
- Statin, CIMT, BES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pravastatin 40mgDrug
Pravastatin 40mg PO daily for 1year from the day of BES implantation
RosuvastatinDrug
Rosuvastatin 20mg PO daily for 1year from the day of BES implantation
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Active comparator | All study subjects will be received percutaneous coronary intervention (PCI) with Biolimus-eluting stent as index procedure at the time of enrollment After index procedure, patients will be randomly assigned to receive pravastatin 40mg or rosuvastatin 20mg in a 1:1 ratio. a> Test group: Pravastatin 40mg PO daily for 1year from the day of BES implantation b> Control group: Rosuvastatin 20mg PO daily for 1year from the day of BES implantation Receives: Drug: Rosuvastatin |
| Pravastatin | Experimental | All study subjects will be received percutaneous coronary intervention (PCI) with Biolimus-eluting stent as index procedure at the time of enrollment After index procedure, patients will be randomly assigned to receive pravastatin 40mg or rosuvastatin 20mg in a 1:1 ratio. a> Test group: Pravastatin 40mg PO daily for 1year from the day of BES implantation b> Control group: Rosuvastatin 20mg PO daily for 1year from the day of BES implantation Receives: Drug: Pravastatin 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of carotid intima media thickness 1 year after pravastatin or rosuvastatin treatment
Measured: 1 year after drug-eluting stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study start12 Jun 2013
- Primary completion25 May 2017
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872845
- Sponsor's protocol ID
- 4-2013-0206
- Status last verified
- Jan 2019
- First submitted
- 4 Jun 2013
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Comparing the Effect of Pravastatin and Rosuvastatin on Atherosclerosis Progression Measured by Carotid Intima Media Thickness in Patients With Coronary Artery Disease After Biolimus Eluting Stent (Nobori®) Implantation: CPR IMT
- ClinicalTrials.gov ID
- NCT01872845
- Acronym / sponsor ID
- 4-2013-0206
- Conditions
- Coronary Artery Occlusive Disease
- Keywords
- Statin, CIMT, BES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 Jun 2013 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 7 Jun 2013 (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.
Current consensus papers recommend statin medication to reduce Low density lipoprotein (LDL) cholesterol level less than 100mg/dL (optional 70mg/dL) in patients with coronary artery disease. However, there is lack of solid evidence whether a specific kind of statin have the superiority against other statins in clinical outcomes. Furthermore, recent data have showed that several kinds of statin could have an adverse effect on glucose metabolism and increase the risk of development of diabetes. Carotid Intimamedia thickness (CIMT) is a surrogate marker of atherosclerosis to predict long term cardiovascular outcomes in not only general population but also patients with established coronary artery disease. Consequently, we will evaluate the efficacy of high dose of pravastatin on CIMT, comparing with moderate dose of rosuvastatin in patients with established coronary artery disease. Additionally, we will assess the clinical outcomes of pravastatin after percutaneous coronary intervention as well as adverse outcomes including insulin resistance and new onset diabetes compared with rosuvastatin. Our main hypothesis is that pravastatin 40mg would be non-inferior to rosuvastatin 20mg regarding CIMT at 1 year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Active comparator | Drug: RosuvastatinAll study subjects will be received percutaneous coronary intervention (PCI) with Biolimus-eluting stent as index procedure at the time of enrollment After index procedure, patients will be randomly assigned to receive pravastatin 40mg or rosuvastatin 20mg in a 1:1 ratio. a> Test group: Pravastatin 40mg PO daily for 1year from the day of BES implantation b> Control group: Rosuvastatin 20mg PO daily for 1year from the day of BES implantation |
| Pravastatin | Experimental | Drug: Pravastatin 40mgAll study subjects will be received percutaneous coronary intervention (PCI) with Biolimus-eluting stent as index procedure at the time of enrollment After index procedure, patients will be randomly assigned to receive pravastatin 40mg or rosuvastatin 20mg in a 1:1 ratio. a> Test group: Pravastatin 40mg PO daily for 1year from the day of BES implantation b> Control group: Rosuvastatin 20mg PO daily for 1year from the day of BES implantation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 20 years old
- Patients with coronary artery disease who are candidate for coronary revascularization with DES implantation.
- Significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis)
- Patients eligible for statin treatment (initial LDL cholesterol >70mg/dL or patients taking lipid-lowering agent)
Key exclusion criteria (3 listed)
- Severe hepatic dysfunction (3 times normal reference values)
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
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 |
|---|---|---|
| Pravastatin 40mgPravastatin 40mg PO daily for 1year from the day of BES implantation | Drug | Pravastatin |
| RosuvastatinRosuvastatin 20mg PO daily for 1year from the day of BES implantation | Drug | Rosuvastatin |
Primary outcome
Change of carotid intima media thickness 1 year after pravastatin or rosuvastatin treatment
Time frame: 1 year after drug-eluting stent implantation
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 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pravastatin 40mg and Rosuvastatin in people with Coronary Artery Occlusive Disease, run by Yonsei 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 4 inclusion and 3 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 Jan 2019. 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?
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?
Change of carotid intima media thickness 1 year after pravastatin or rosuvastatin treatment (time frame: 1 year after drug-eluting stent implantation). 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 Jan 2019.