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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

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ClinicalTrials.gov Identifier: NCT01872845
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Occlusive Disease Drug: Pravastatin 40mg Drug: Rosuvastatin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 671 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : June 12, 2013
Actual Primary Completion Date : May 25, 2017
Actual Study Completion Date : May 25, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change of carotid intima media thickness 1 year after pravastatin or rosuvastatin treatment [ Time Frame: 1 year after drug-eluting stent implantation ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872845


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01872845     History of Changes
Other Study ID Numbers: 4-2013-0206
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019

Keywords provided by Yonsei University:
Statin
CIMT
BES

Additional relevant MeSH terms:
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Rosuvastatin Calcium
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors