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

NCT01872845 | Completed

• 1 other identifier: 4-2013-0206
• Study Type: interventional
• Target: 671
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Occlusive Disease

Keywords

Statin; CIMT; BES

Outcome Measures

Primary Outcomes (1)

• Change of carotid intima media thickness 1 year after pravastatin or rosuvastatin treatment

  1 year after drug-eluting stent implantation

Study Arms (2)

Rosuvastatin

ACTIVE COMPARATOR

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

Pravastatin

EXPERIMENTAL

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

Interventions

Pravastatin 40mg DRUG

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

Pravastatin

Rosuvastatin DRUG

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

Rosuvastatin

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Severe hepatic dysfunction (3 times normal reference values)
• Pregnant women or women with potential childbearing
• Life expectancy \< 1 year

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Pravastatin; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 7, 2013
• Study Start: June 12, 2013
• Primary Completion: May 25, 2017
• Study Completion: May 25, 2017
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

KR (1)