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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Kumamoto University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kumamoto University
ClinicalTrials.gov Identifier:
NCT00861861
First received: March 12, 2009
Last updated: March 13, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Hypercholesterolemia
Coronary Artery Disease
 Drug: Pitavastatin
Drug: Atorvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Pitavastatin With Atorvastatin in Increasing HDL-C and Adiponectin in Patients With Dislipidemia and Coronary Artery Disease.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin) [ Time Frame: start, 6 months, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • TC; LDL-C; HDL-C; HDL2-C; HDL3-C; TG; smallenseLDL; MDA-LDL; FPG; HbA1c; insulin;GLP-1;DPP-Ⅳ;RLP-C; apoA-I;apoB;apoC-Ⅱ; apoC-Ⅲ; hs-CRP; VWF; sICAM-1; ADAMTS13; Platelet-derived microparticles; MPO [ Time Frame: start, 6 months, 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
pitavastatin group
 Drug: Pitavastatin
comparison of two drugs in increasing HDL-C and adiponectin
Other Name: Pitavastatin
Active Comparator: 2
atorvastatin group
 Drug: Atorvastatin
comparison of two drugs in increasing HDL-C and adiponectin
Other Name: Atorvastatin

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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    • LDL-C ≥ 140 mg/dL
    • LDL-C ≥ 100 mg/dL and cholesterol-lowering treatment is necessary in accordance with the investigator's judgemen
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861861

Contacts
Contact: Hisao Ogawa, MD, PhD +81-96-373-5175 ogawah@kumamoto-u.ac.jp
Contact: Seigo Sugiyama, MD, PhD +81-96-373-5175 ssuiyam@kumamoto-u.ac.jp

Locations
Japan
Kumamoto University Graduate School of Medical Sciences Department of Cardiocascular Medicine Recruiting
Kumamoto, Japan, 860-8556
Contact: Hisao Ogawa, MD, PhD     +81-96-373-5175        
Sponsors and Collaborators
Kumamoto University
Investigators
Principal Investigator: Hisao Ogawa, MD,PhD Kumamoto University Graduate School of Medical Sciences
  More Information

No publications provided

Responsible Party: Hisao Ogawa, Kumamoto University
ClinicalTrials.gov Identifier: NCT00861861     History of Changes
Other Study ID Numbers: Kumamoto-746
Study First Received: March 12, 2009
Last Updated: March 13, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kumamoto University:
Pitavastatin
Atorvastatin
CAD
HDL-C
Adiponectin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypercholesterolemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Atorvastatin
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013