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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)

K

Kumamoto University

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease
Hypercholesterolemia

Treatments

Drug: Pitavastatin
Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00861861
Kumamoto-746

Details and patient eligibility

About

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.

Full 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.

Enrollment

129 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

129 participants in 2 patient groups

1
Active Comparator group
Description:
pitavastatin group
Treatment:
Drug: Pitavastatin
2
Active Comparator group
Description:
atorvastatin group
Treatment:
Drug: Atorvastatin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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