Fluvastatin AmelIorates aTHerosclerosis Study (FAITH)

This study is currently recruiting participants.

Verified September 2012 by Beijing Anzhen Hospital

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

Tracking Information
First Received Date ^ICMJE	September 5, 2012
Last Updated Date	September 5, 2012
Start Date ^ICMJE	July 2012
Estimated Primary Completion Date	April 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 5, 2012)	carotid IMT [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: September 5, 2012)	lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I [ Time Frame: week 12 and 24 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE (submitted: September 5, 2012)	hs-CRP, Lp-PLA2, OPN and OPG. [ Time Frame: week 12,24 and 52 ] [ Designated as safety issue: No ]
Original Other Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Fluvastatin AmelIorates aTHerosclerosis Study
Official Title ^ICMJE	The Efficacy of Lescol XL(Fluvastatin Extended Release 80 mg) on Atherosclerosis Progression in Patients With Newly Diagnosed Coronary Heart Disease
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 Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Coronary Heart Disease Atherosclerosis
Intervention ^ICMJE	Drug: Fluvastatin extended release tablet Other Name: Lescol XL
Study Arm (s)	Experimental: Fluvastatin extended release tablet Fluvastatin extended release tablet 80mg/day Intervention: Drug: Fluvastatin extended release tablet
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	140
Estimated Completion Date	August 2014
Estimated Primary Completion Date	April 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	45 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01681199
Other Study ID Numbers ^ICMJE	AZYY-XNK-2012001
Has Data Monitoring Committee	No
Responsible Party	Chang sheng Ma, Beijing Anzhen Hospital
Study Sponsor ^ICMJE	Beijing Anzhen Hospital
Collaborators ^ICMJE	Novartis
Investigators ^ICMJE	Not Provided
Information Provided By	Beijing Anzhen Hospital
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top