Fluvastatin AmelIorates aTHerosclerosis Study (FAITH)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2012 by Beijing Anzhen Hospital.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Novartis

Information provided by (Responsible Party):

Chang sheng Ma, Beijing Anzhen Hospital

ClinicalTrials.gov Identifier:

NCT01681199

First received: September 5, 2012

Last updated: NA

Last verified: September 2012

History: No changes posted

Purpose

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	Intervention	Phase
Coronary Heart Disease Atherosclerosis	Drug: Fluvastatin extended release tablet	Phase 4


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Coronary Artery Disease Heart Diseases

Drug Information available for: Fluvastatin Fluvastatin sodium

U.S. FDA Resources

Further study details as provided by Beijing Anzhen Hospital:

Primary Outcome Measures:

carotid IMT [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I [ Time Frame: week 12 and 24 ] [ Designated as safety issue: No ]

Other Outcome Measures:

hs-CRP, Lp-PLA2, OPN and OPG. [ Time Frame: week 12,24 and 52 ] [ Designated as safety issue: No ]


Estimated Enrollment:	140
Study Start Date:	July 2012
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fluvastatin extended release tablet Fluvastatin extended release tablet 80mg/day	Drug: Fluvastatin extended release tablet Other Name: Lescol XL

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 .

Eligibility


Ages Eligible for Study:	45 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681199

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

No publications provided


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
Study First Received:	September 5, 2012
Last Updated:	September 5, 2012
Health Authority:	China: Ethics Committee

Keywords provided by Beijing Anzhen Hospital:


statin atherosclerosis Coronary heart disease OPN OPG

Additional relevant MeSH terms:


Arteriosclerosis Atherosclerosis Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Arterial Occlusive Diseases Cardiovascular Diseases Vascular Diseases Fluvastatin	Anticholesteremic Agents Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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