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

January 17, 2019 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

671

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of carotid intima media thickness 1 year after pravastatin or rosuvastatin treatment
Time Frame: 1 year after drug-eluting stent implantation
1 year after drug-eluting stent implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2013

Primary Completion (Actual)

May 25, 2017

Study Completion (Actual)

May 25, 2017

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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