Fluvastatin AmelIorates aTHerosclerosis Study

Phase 4

• Conditions: Coronary Heart Disease; Atherosclerosis
• Interventions: Drug: Fluvastatin extended release tablet

• Registration Number: NCT01681199
• Lead Sponsor: Beijing Anzhen Hospital

Brief 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.

Detailed Description

Carotid IMT has been used in various studies (e.g. ASAP, ARBITER, METEOR) and is well accepted as a valid surrogate marker for atherosclerosis. The thickness of CIMT is significantly associated with the presence and the extent of coronary disease. Slower progression of atherosclerosis as measured by carotid ultrasound is also associated with a lower risk of nonfatal MI. In a meta analysis, for every 0.0 1-mm-per-year decrease in carotid IMT, there was a significant 18% reduction in the risk of nonfatal MI. Measurement of carotid IMT carries the advantage of being non-invasive and easy to use with a good degree of reproducibility.

Statins have been shown to slow the progression of atherosclerosis or even to induce regression of atherosclerosis. Change of carotid IMT by statins have been found to correlate with the extent of LDL-C reduction and HDL-C increase however non-lipid effects (e.g. effects on inflammation, calcification ) may also play a role in the beneficial effects of statins on atherosclerosis.Osteopontin (OPN), an acidic phosphoprotein, and osteoprotegerin (OPG), a member of the tumor necrosis factor-a receptor superfamily, have been recently demonstrated to modulate vascular calcification. Recent studies have shown an association of serum OPN and OPG levels with cardiovascular diseases and vulnerable carotid plaque .

Study Timeline

• Study Start: 2012-07
• Status Verified: 2012-09
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-05
• Last Update Submitted: 2012-09-05
• Study First Posted: 2012-09-07
• Last Update Posted: 2012-09-07
• Primary Completion: 2014-04
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluvastatin extended release tablet	Fluvastatin extended release tablet	Fluvastatin extended release tablet 80mg/day

Primary Outcome Measures

Name	Time	Method
carotid IMT	1 year

Secondary Outcome Measures

Name	Time	Method
lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I	week 12 and 24

Trial Locations

Locations (1)

Cardiology department ,Beijing Anzhen hospital; 🇨🇳 Beijing, Beijing, China