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Fluvastatin AmelIorates aTHerosclerosis Study (FAITH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Chang sheng Ma, Beijing Anzhen Hospital

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01681199

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China, Beijing
Cardiology department ,Beijing Anzhen hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Xin Du, PhD    86 15010519643   
Sub-Investigator: Xin Du, PhD         
Sponsors and Collaborators
Beijing Anzhen Hospital
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Responsible Party: Chang sheng Ma, director of cardiology department, Beijing Anzhen Hospital Identifier: NCT01681199    
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:
Coronary heart disease
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases