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South Korean Pitavastatin Heart Failure Study (SAPHIRE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00701285
First Posted: June 19, 2008
Last Update Posted: May 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JW Pharmaceutical
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • Rate and number of hospitalization for cardiovascular cause; Lipid profile [ Time Frame: 52week ]

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

Estimated Enrollment: 70
Study Start Date: July 2008
Study Completion Date: May 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
strong statin
Drug: pitavastatin
pitavastatin 4mg once daily
Active Comparator: 2
mild statin
Drug: pravastatin
pravastatin 10mg once daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701285


Locations
Korea, Republic of
SEOUL St. Mary's Hospital
Seoul, Seocho-Ku, Korea, Republic of, 137-040
Sponsors and Collaborators
JW Pharmaceutical
Investigators
Study Chair: Sang Hong Baek, MD, PhD KangNam St. Mary's Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT00701285     History of Changes
Other Study ID Numbers: CWP-PTV-703
First Submitted: June 17, 2008
First Posted: June 19, 2008
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by JW Pharmaceutical:
heart failure
pitavastatin
pravastatin
statin

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pravastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents