Fluvastatin AmelIorates aTHerosclerosis Study (FAITH)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Coronary Heart Disease; Atherosclerosis	Drug: Fluvastatin extended release tablet	Phase 4

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 Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Fluvastatin extended release tablet; Fluvastatin extended release tablet 80mg/day	Drug: Fluvastatin extended release tablet; Other Name: Lescol XL

Outcome Measures

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Primary Outcome Measures :

1. carotid IMT [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I [ Time Frame: week 12 and 24 ]

Other Outcome Measures:

1. hs-CRP, Lp-PLA2, OPN and OPG. [ Time Frame: week 12,24 and 52 ]

Eligibility Criteria

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Ages Eligible for Study:	45 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Beijing Anzhen Hospital

Novartis

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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