Fluvastatin AmelIorates aTHerosclerosis Study (FAITH)
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ClinicalTrials.gov Identifier: NCT01681199 |
Recruitment Status
: Unknown
Verified September 2012 by Chang sheng Ma, Beijing Anzhen Hospital.
Recruitment status was: Recruiting
First Posted
: September 7, 2012
Last Update Posted
: September 7, 2012
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Condition or disease | Intervention/treatment | Phase |
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Coronary Heart Disease Atherosclerosis | Drug: Fluvastatin extended release tablet | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Efficacy of Lescol XL(Fluvastatin Extended Release 80 mg) on Atherosclerosis Progression in Patients With Newly Diagnosed Coronary Heart Disease |
Study Start Date : | July 2012 |
Estimated Primary Completion Date : | April 2014 |
Estimated Study Completion Date : | August 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Fluvastatin extended release tablet
Fluvastatin extended release tablet 80mg/day
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Drug: Fluvastatin extended release tablet
Other Name: Lescol XL
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- carotid IMT [ Time Frame: 1 year ]
- lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I [ Time Frame: week 12 and 24 ]
- hs-CRP, Lp-PLA2, OPN and OPG. [ Time Frame: week 12,24 and 52 ]

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Ages Eligible for Study: | 45 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Newly diagnosed coronary heart disease
- One or more maximum IMT measurements of ≥1.1mm.
- Age 45 to 70 years old
- LDL-C≥130mg/dL
- Not receiving regular lipid lowering treatment
- Written Informed Consent
Exclusion Criteria:
- Myocardial infarction as the first symptoms of coronary heart disease
- Patients with known hypersensitivity to fluvastatin or any of the excipients
- Pregnancy or lactation, or women of childbearing potential not using effective contraception
- 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)
- renal dysfunction
- Active liver disease and/or serum transaminase levels (ALT, AST) greater than 2x ULN
- Any conditions the investigator consider not suitable for long-term follow up

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681199
China, Beijing | |
Cardiology department ,Beijing Anzhen hospital | Recruiting |
Beijing, Beijing, China, 100029 | |
Contact: Xin Du, PhD 86 15010519643 duxinheart@sina.com | |
Sub-Investigator: Xin Du, PhD |
Responsible Party: | Chang sheng Ma, director of cardiology department, Beijing Anzhen Hospital |
ClinicalTrials.gov Identifier: | NCT01681199 History of Changes |
Other Study ID Numbers: |
AZYY-XNK-2012001 |
First Posted: | September 7, 2012 Key Record Dates |
Last Update Posted: | September 7, 2012 |
Last Verified: | September 2012 |
Keywords provided by Chang sheng Ma, Beijing Anzhen Hospital:
statin atherosclerosis Coronary heart disease OPN OPG |
Additional relevant MeSH terms:
Heart Diseases Atherosclerosis Coronary Disease Coronary Artery Disease Myocardial Ischemia Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Fluvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |