Fluvastatin AmelIorates aTHerosclerosis Study

• Status: Unknown status
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Anzhen Hospital
• Collaborator: Novartis
• Treatments: Fluvastatin

Criteria

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