Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)

Phase 4

Completed

• Conditions: Hypercholesterolemia; Coronary Artery Disease
• Interventions: Drug: Pitavastatin; Drug: Atorvastatin

• Registration Number: NCT00861861
• Lead Sponsor: Kumamoto University

Brief Summary

The purpose of this study is to compare the effects of pitavastatin and atorvastatin on adiponectin percentage change in patients with hypercholesteremia comorbid stable CAD.

Detailed Description

The efficiency of lipid lowering therapy was already proven by the clinical trials of statins. According to these results, the target value of LDL-C is recommended under 100mg/dL in the Japan Atherosclerosis Society Guidelines. However, the efficiency of intensive therapy to lower LDL-C more than 100mg/dL has not been proven yet.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-13
• Study First Posted: 2009-03-16
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-11
• Last Update Posted: 2013-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Patients with dyslipidemia as defined by any of the parameters:

  • HDL-C < 50 mg/dL
  • LDL-C ≥ 140 mg/dL
  • LDL-C ≥ 100 mg/dL and cholesterol-lowering treatment is necessary in accordance with the investigator's judgement

• Patients who passed three months or more after acute myocardial infarction

• Patients who passed one month or more after unstable angina

• Patients who passed one month or more after PCI

• Patients with written consent by their own volition after being provided sufficient explanation for the participation into this clinical trial

Exclusion Criteria

• Patients with any allergy to pitavastatin or atorvastatin
• Patients with familial hypercholesterolemia
• Patients receiving pitavastatin
• Patients with severe hypertension
• Patients with renal disorders or undergoing dialysis
• Patients with hepatobiliary disorders
• Patients with hepatobiliary disorders
• Patients with family history of hypothyroidism or muscular dystrophy
• Patients with history of drug-induced hepatic disorder
• Drug abuser or dipsomaniac
• Patients with cardiogenic shock.
• Patients who hopes for pregnancy during this study
• Contraindications, Relative Contraindications, Absolute Contraindications for Coadministration and Relative Contraindications for Coadministration for pitavastatin or atorvastatin
• Patients who are ineligible in the opinion of the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pitavastatin	pitavastatin group
2	Atorvastatin	atorvastatin group

Primary Outcome Measures

Name	Time	Method
HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin)	start, 6 months, 12 months, 30 months

Secondary Outcome Measures

Name	Time	Method
TC; LDL-C; HDL-C; HDL2-C; HDL3-C; TG; smalldenseLDL; MDA-LDL; FPG; HbA1c; Cr; RLP-C; apoA-I; apoB; apoC-Ⅱ; apoC-Ⅲ	start, 6 months, 12 months, 30 months

Trial Locations

Locations (1)

Kumamoto University Graduate School of Medical Sciences Department of Cardiocascular Medicine; 🇯🇵 Kumamoto, Japan