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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

671 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-12

Study Completion Date

2017-05-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Occlusive Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

Rosuvastatin 20mg PO daily for 1year from the day of BES implantation

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

Group Type EXPERIMENTAL

Pravastatin 40mg

Intervention Type DRUG

Pravastatin 40mg PO daily for 1year from the day of BES implantation

Interventions

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Pravastatin 40mg

Pravastatin 40mg PO daily for 1year from the day of BES implantation

Intervention Type DRUG

Rosuvastatin

Rosuvastatin 20mg PO daily for 1year from the day of BES implantation

Intervention Type DRUG

Eligibility Criteria

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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)