Official Title: “A Prospective, Randomized, Two Group Comparison Study to Evaluate the Effect of Statin on Heart Function in Patients With Chronic Ischemic Heart Failure.”

We want to evaluate the utility of statins on heart function according to potency. Patients with chronic ischemic heart failure are administered pitavastatin 4mg or pravastatin 10mg for 52 weeks. Then we evaluate the effect of pitavastatin and pravastatin primarily on rate of hospitalization for cardiovascular cause and lipid profile secondarily biomarker, echocardiography parameter, 6-minute walk, change of NYHA class distribution, cardiovascular mortality.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: pitavastatin
  • pitavastatin 4mg once daily
• Drug: pravastatin
  • pravastatin 10mg once daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • strong statin
• Active Comparator: 2
  • mild statin

Primary Measures

• Rate and number of hospitalization for cardiovascular cause; Lipid profile
  • Time Frame: 52week
    Safety Issue?: Yes

Secondary Measures

• Biomarker : BNP, hsCRP, IL-6. TNF-α
  • Time Frame: 52 week
    Safety Issue?: Yes
• Echocardiography : LVEF, E/A ratio, LVEDD, LVESD
  • Time Frame: 52 week
    Safety Issue?: Yes
• Cardiac function evaluation (NYHA class distribution, 6-minute walk test)
  • Time Frame: 52 week
    Safety Issue?: Yes
• Cardiovascular mortality
  • Time Frame: 52 week
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Patients who accepted to enter the study by written informed consent
• 2. Age ≥ 30 years
• 3. LDL-cholesterol ≥ 70mg/dl
• 4. Chronic heart failure of :
• NYHA class II ~ III
• Ischemic etiology
• Left ventricular ejection fraction < 45%
• Optimal therapy for chronic heart failure and stable clinical condition over the two weeks.

Exclusion Criteria:

• 1. Patients who participated in other studies 3 months before enrollment
• 2. Statin treatment within 2 months before enrollment
• 3. Unstable decompensated heart failure at enrollment
• 4. Acute coronary syndrome or cerebral vascular disease within 3 months before enrollment
• 5. Coronary revascularization within 3 months before enrollment or planned at enrollment
• 6. Any other serious disease or condition which might effect life expectancy such as malignancy, life-threatening infectious disease.
• 7. Serum creatinine levels >= 3.0 mg/dl
• 8. AST or AST levels >=2.5 times of ULN
• 9. CK levels >=2 times of ULN
• 10. Uncontrolled hypothyroidism : TSH level >= 2 times of ULN
• 11. Pregnant or breastfeeding women, women who want to bearing
• 12. Patients who might to be unsuitable by the decision of investigators

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: ChoongWae Pharma Corporation

Overall Clinical Trial Officials and Contacts

Sang Hong Baek, MD, PhD Study Chair KangNam St. Mary's Hospital  

Overall Contact: Sang Hong Baek, MD, PhD 82-2-590-2709 whitesh@catholic.ac.kr

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00701285

Study ID Number: CWP-PTV-703

ClinicalTrials.gov Identifier: NCT00701285

Health Authority: South Korea: Institutional Review Board