South Korean Pitavastatin Heart Failure Study - Full Text View

Sponsored by:	ChoongWae Pharma Corporation
Information provided by:	ChoongWae Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00701285

Purpose

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.

Condition	Intervention	Phase
Chronic Heart Failure	Drug: pitavastatin Drug: pravastatin	Phase IV

MedlinePlus related topics: Heart Failure Statins

Drug Information available for: Pravastatin Pravastatin sodium Pitavastatin NK 104

U.S. FDA Resources

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

Further study details as provided by ChoongWae Pharma Corporation:

Primary Outcome Measures:

Rate and number of hospitalization for cardiovascular cause; Lipid profile [ Time Frame: 52week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Biomarker : BNP, hsCRP, IL-6. TNF-α [ Time Frame: 52 week ] [ Designated as safety issue: Yes ]
Echocardiography : LVEF, E/A ratio, LVEDD, LVESD [ Time Frame: 52 week ] [ Designated as safety issue: Yes ]
Cardiac function evaluation (NYHA class distribution, 6-minute walk test) [ Time Frame: 52 week ] [ Designated as safety issue: Yes ]
Cardiovascular mortality [ Time Frame: 52 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	July 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator strong statin	Drug: pitavastatin pitavastatin 4mg once daily
2: Active Comparator mild statin	Drug: pravastatin pravastatin 10mg once daily

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who accepted to enter the study by written informed consent
Age ≥ 30 years
LDL-cholesterol ≥ 70mg/dl
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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701285

Contacts

Contact: Sang Hong Baek, MD, PhD

82-2-590-2709

whitesh@catholic.ac.kr

Locations

Korea, Republic of, 505 Banpo-Dong, Seocho-Ku
KangNam St. Mary's Hospital	Recruiting
Seoul, 505 Banpo-Dong, Seocho-Ku, Korea, Republic of, 137-040
Contact: Sang Hong Baek, MD, PhD 82-2-590-2709 whitesh@catholic.ac.kr

Sponsors and Collaborators

ChoongWae Pharma Corporation

Investigators

Study Chair:

Sang Hong Baek, MD, PhD

KangNam St. Mary's Hospital

More Information

No publications provided

Responsible Party:	KangNam St. Mary's Hospital ( Sang Hong Baek, MD, PhD )
Study ID Numbers:	CWP-PTV-703
Study First Received:	June 17, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00701285 History of Changes
Health Authority:	South Korea: Institutional Review Board

Keywords provided by ChoongWae Pharma Corporation:

heart failure
pitavastatin
pravastatin
statin

Study placed in the following topic categories:

Antimetabolites
Pravastatin
Heart Failure
Heart Diseases
NK 104

Antilipemic Agents
Anticholesteremic Agents
Ischemia
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Additional relevant MeSH terms:

Antimetabolites
Heart Failure
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Pravastatin
NK 104
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009