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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Occlusive Disease

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pravastatin 40mg

Drug

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

Rosuvastatin

Drug

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

Primary outcomes

Change of carotid intima media thickness 1 year after pravastatin or rosuvastatin treatment

Time frame: 1 year after drug-eluting stent implantation

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Jun 7, 2013
Registry last updated: Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed