Atherosclerosis Clinical Trial
— FAITHOfficial title:
The Efficacy of Lescol XL(Fluvastatin Extended Release 80 mg) on Atherosclerosis Progression in Patients With Newly Diagnosed Coronary Heart Disease
Verified date | September 2012 |
Source | Beijing Anzhen Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
The study is designed to assess the effect of statin on atherosclesrosis progression as well as to explore its potential mechanism besides lipid modifying , such as effect on inflammation and vascular calcification.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | August 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Newly diagnosed coronary heart disease 2. One or more maximum IMT measurements of =1.1mm. 3. Age 45 to 70 years old 4. LDL-C=130mg/dL 5. Not receiving regular lipid lowering treatment 6. Written Informed Consent Exclusion Criteria: 1. Myocardial infarction as the first symptoms of coronary heart disease 2. Patients with known hypersensitivity to fluvastatin or any of the excipients 3. Pregnancy or lactation, or women of childbearing potential not using effective contraception 4. Known muscle disease or history of muscle disease (e.g. myopathy, myositis, rhabdomyolysis) and/or serum CK levels greater than 2 x upper limit of normal (ULN) 5. renal dysfunction 6. Active liver disease and/or serum transaminase levels (ALT, AST) greater than 2x ULN 7. Any conditions the investigator consider not suitable for long-term follow up |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Cardiology department ,Beijing Anzhen hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Anzhen Hospital | Novartis |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | hs-CRP, Lp-PLA2, OPN and OPG. | week 12,24 and 52 | No | |
Primary | carotid IMT | 1 year | No | |
Secondary | lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I | week 12 and 24 | No |
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