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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01872845

Collaborator

(none)

671

Enrollment

Location

Arms

47.4

Actual Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Occlusive Disease	Drug: Pravastatin 40mg Drug: Rosuvastatin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

671 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Actual Study Start Date :

Jun 12, 2013

Actual Primary Completion Date :

May 25, 2017

Actual Study Completion Date :

May 25, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rosuvastatin 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	Drug: Rosuvastatin Rosuvastatin 20mg PO daily for 1year from the day of BES implantation
Experimental: Pravastatin 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	Drug: Pravastatin 40mg Pravastatin 40mg PO daily for 1year from the day of BES implantation

Arm

Intervention/Treatment

Active Comparator: Rosuvastatin

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

Drug: Rosuvastatin

Rosuvastatin 20mg PO daily for 1year from the day of BES implantation

Experimental: Pravastatin

Drug: Pravastatin 40mg

Pravastatin 40mg PO daily for 1year from the day of BES implantation

Outcome Measures

Primary Outcome Measures

Change of carotid intima media thickness 1 year after pravastatin or rosuvastatin treatment [1 year after drug-eluting stent implantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

Severe hepatic dysfunction (3 times normal reference values)
Pregnant women or women with potential childbearing
Life expectancy < 1 year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01872845

Other Study ID Numbers:

4-2013-0206

First Posted:

Jun 7, 2013

Last Update Posted:

Jan 22, 2019

Last Verified:

Jan 1, 2019

Keywords provided by Yonsei University

Statin

CIMT

BES

Additional relevant MeSH terms:

Rosuvastatin Calcium

Pravastatin

Study Results

No Results Posted as of Jan 22, 2019