Fluvastatin AmelIorates aTHerosclerosis Study (FAITH)

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Coronary Heart Disease; Atherosclerosis

Treatments: Drug: Fluvastatin extended release tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01681199

AZYY-XNK-2012001

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 140 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Fluvastatin extended release tablet

Experimental group

Description:

Fluvastatin extended release tablet 80mg/day

Treatment:

Drug: Fluvastatin extended release tablet