The identification of risk factors for cardiovascular disease in koreans and development of prospective trials to validate the efficacy of risk modification for the prevention of cardiovascular disease

Randomized, multicenter, open-labeled, two-arm parallel group trial of pitavastatin 2 mg OD for reducing the risk of major cardiovascular events in patients with clustering cardiovascular risk factors

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000001

Enrollment

2062

Registered

2010-02-11

Start date

2009-05-14

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Administration of pitavastatin 2 mg one tablet, once a day in the morning or non-medication - Follow-up for 60 months after LPI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Acquisition of consent form 2. Total cholesterol level of less than 220mg/dl Should have at least one of categories listed in the item 3. or 4. 3. Clearly diagnosed as diabetes and should have at least two of those listed as follows; - Age ; male 45YO or more, female 55YO or more - Current smoker - Diagnosed as hypertension - Low HDL cholesterol levels <40 mg/dl - Abdominal obesity (male; 90 cm or more, female; 85 cm or more of waist circumferences) 4. Non-diabetics, but calculated 10-year-risk for cardiovascular disease (offered by NCEP-III guideline) equals or more than 20 % and diagnosed as metabolic syndrome.

Exclusion criteria

Exclusion criteria: 1. Age of 80 YO or more 2. History of uncontrolled endocrinologic diseases; such as hypothyroidism, hypopituitarism, or others. 3. Pregnancy 4. Azotemia 5. HIV positive 6. Abnormal serum levels of liver (AST, ALT) and muscle (CK) enzymes 7. History of neoplasm 8. History of overt cardiovascular disease 9. Hear failure 10. Triglyceride levels > 400mg/dl 11. Total cholesterol levels 11.0%

Design outcomes

Primary

Measure	Time frame
Myocardial infarction, stroke, Cardiovascular death, Hospitalization due to unstable angina, TIA, the development of atherosclerotic	—

Secondary

Measure	Time frame
Primary outcome + The development of atherosclerotic narrowing or myocardial ischemia, Death of any cause	—

Countries

Korea, Republic of

Contacts

Public ContactEun-jung Kim

Asan Medical Center

Outcome results