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

Sponsor

Kumamoto University (Other)

Overall Status

Completed

CT.gov ID

NCT00861861

Collaborator

(none)

129

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia Coronary Artery Disease	Drug: Pitavastatin Drug: Atorvastatin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Pitavastatin With Atorvastatin in Increasing HDL-C and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease.

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 pitavastatin group	Drug: Pitavastatin comparison of two drugs in increasing HDL-C and adiponectin
Active Comparator: 2 atorvastatin group	Drug: Atorvastatin comparison of two drugs in increasing HDL-C and adiponectin

Arm

Intervention/Treatment

Active Comparator: 1

pitavastatin group

Drug: Pitavastatin

comparison of two drugs in increasing HDL-C and adiponectin

Active Comparator: 2

atorvastatin group

Drug: Atorvastatin

comparison of two drugs in increasing HDL-C and adiponectin

Outcome Measures

Primary Outcome Measures

HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin) [start, 6 months, 12 months, 30 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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