NCT01872845

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 671 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Occlusive Disease

Interventions

Type	Name	Description
DRUG	Pravastatin 40mg	Pravastatin 40mg PO daily for 1year from the day of BES implantation
DRUG	Rosuvastatin	Rosuvastatin 20mg PO daily for 1year from the day of BES implantation

Timeline

• Start date: 2013-06-12
• Primary completion: 2017-05-25
• Completion: 2017-05-25
• First posted: 2013-06-07
• Last updated: 2019-01-22

Locations

1 site across 1 country: South Korea