South Korean Pitavastatin Heart Failure Study (SAPHIRE)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by JW Pharmaceutical.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
JW Pharmaceutical
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00701285
First received: June 17, 2008
Last updated: October 4, 2012
Last verified: April 2010
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 ] [ 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 Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 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| 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
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
No publications provided
| Responsible Party: | JW Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT00701285 History of Changes |
| Other Study ID Numbers: | CWP-PTV-703 |
| Study First Received: | June 17, 2008 |
| Last Updated: | October 4, 2012 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by JW Pharmaceutical:
|
heart failure pitavastatin pravastatin statin |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Pravastatin Pitavastatin Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013