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

Coronary Artery Occlusive Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872845
• Other study ID #: 4-2013-0206
• Status: Completed
• Phase: N/A
• Start date: June 12, 2013
• Est. completion date: May 25, 2017

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 671
• Est. completion date: May 25, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Occlusive Disease

Intervention

Drug:
• Pravastatin 40mg
Pravastatin 40mg PO daily for 1year from the day of BES implantation
• Rosuvastatin
Rosuvastatin 20mg PO daily for 1year from the day of BES implantation

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of carotid intima media thickness 1 year after pravastatin or rosuvastatin treatment		1 year after drug-eluting stent implantation