Clinical trial NCT00861861: Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)
Official title: Comparison of Pitavastatin With Atorvastatin in Increasing HDL-C and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Coronary Artery Disease
Keywords: Pitavastatin
Atorvastatin
CAD
HDL-C
Adiponectin
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2009-03-16
Enrollment: 129
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin)
timeFrame: start, 6 months, 12 months, 30 months
Secondary outcomes:
measure: 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
timeFrame: start, 6 months, 12 months, 30 months
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Kumamoto University Graduate School of Medical Sciences Department of Cardiocascular Medicine
Study officials:
affiliation: Kumamoto University Graduate School of Medical Sciences
name: Hisao Ogawa, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: