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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

September 5, 2012
September 5, 2012
July 2012
April 2014   (final data collection date for primary outcome measure)
carotid IMT [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I [ Time Frame: week 12 and 24 ] [ Designated as safety issue: No ]
Same as current
hs-CRP, Lp-PLA2, OPN and OPG. [ Time Frame: week 12,24 and 52 ] [ Designated as safety issue: No ]
Same as current
 
Fluvastatin AmelIorates aTHerosclerosis Study
The Efficacy of Lescol XL(Fluvastatin Extended Release 80 mg) on Atherosclerosis Progression in Patients With Newly Diagnosed Coronary Heart Disease

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.

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 .

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Heart Disease
  • Atherosclerosis
Drug: Fluvastatin extended release tablet
Other Name: Lescol XL
Experimental: Fluvastatin extended release tablet
Fluvastatin extended release tablet 80mg/day
Intervention: Drug: Fluvastatin extended release tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
August 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
45 Years to 70 Years
No
China
 
NCT01681199
AZYY-XNK-2012001
No
Chang sheng Ma, Beijing Anzhen Hospital
Beijing Anzhen Hospital
Novartis
Not Provided
Beijing Anzhen Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP