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

Last updated: January 17, 2019
Sponsor: Yonsei University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01872845
4-2013-0206
  • Ages 20-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 20 years old

  • Patients with coronary artery disease who are candidate for coronary revascularizationwith DES implantation.

  • Significant coronary de novo lesion (stenosis > 70% by quantitative angiographicanalysis)

  • Patients eligible for statin treatment (initial LDL cholesterol >70mg/dL or patientstaking lipid-lowering agent)

Exclusion

Exclusion Criteria:

  • Severe hepatic dysfunction (3 times normal reference values)

  • Pregnant women or women with potential childbearing

  • Life expectancy < 1 year

Study Design

Total Participants: 671
Study Start date:
June 12, 2013
Estimated Completion Date:
May 25, 2017

Connect with a study center

  • Severance Hospital

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

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