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

Coronary Artery Disease Clinical Trial

— COMPACT-CAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861861
• Other study ID #: Kumamoto-746
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2009
• Last updated: October 11, 2013
• Start date: September 2008
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Dyslipidemias
• Hypercholesterolemia
• Myocardial Ischemia

Intervention

Drug:
• Pitavastatin
comparison of two drugs in increasing HDL-C and adiponectin
• Atorvastatin
comparison of two drugs in increasing HDL-C and adiponectin

Locations

Country	Name	City	State
Japan	Kumamoto University Graduate School of Medical Sciences Department of Cardiocascular Medicine	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin)		start, 6 months, 12 months, 30 months	Yes
Secondary	TC; LDL-C; HDL-C; HDL2-C; HDL3-C; TG; smalldenseLDL; MDA-LDL; FPG; HbA1c; Cr; RLP-C; apoA-I; apoB; apoC-?; apoC-?		start, 6 months, 12 months, 30 months	Yes