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

Primary Purpose

Hypercholesterolemia, Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Pitavastatin
Atorvastatin
Sponsored by
Kumamoto University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Pitavastatin, Atorvastatin, CAD, HDL-C, Adiponectin

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kumamoto University Graduate School of Medical Sciences Department of Cardiocascular Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

pitavastatin group

atorvastatin group

Outcomes

Primary Outcome Measures

HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin)

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

Full Information

First Posted
March 12, 2009
Last Updated
October 11, 2013
Sponsor
Kumamoto University
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1. Study Identification

Unique Protocol Identification Number
NCT00861861
Brief Title
Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)
Acronym
COMPACT-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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kumamoto University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Coronary Artery Disease
Keywords
Pitavastatin, Atorvastatin, CAD, HDL-C, Adiponectin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
pitavastatin group
Arm Title
2
Arm Type
Active Comparator
Arm Description
atorvastatin group
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Description
comparison of two drugs in increasing HDL-C and adiponectin
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
comparison of two drugs in increasing HDL-C and adiponectin
Primary Outcome Measure Information:
Title
HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin)
Time Frame
start, 6 months, 12 months, 30 months
Secondary Outcome Measure Information:
Title
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
Time Frame
start, 6 months, 12 months, 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisao Ogawa, MD,PhD
Organizational Affiliation
Kumamoto University Graduate School of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kumamoto University Graduate School of Medical Sciences Department of Cardiocascular Medicine
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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