Fluvastatin AmelIorates aTHerosclerosis Study (FAITH)
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease Atherosclerosis||Drug: Fluvastatin extended release tablet||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Fluvastatin extended release tablet
Fluvastatin extended release tablet 80mg/day
Drug: Fluvastatin extended release tablet
Other Name: Lescol XL
- carotid IMT [ Time Frame: 1 year ]
- lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I [ Time Frame: week 12 and 24 ]
- hs-CRP, Lp-PLA2, OPN and OPG. [ Time Frame: week 12,24 and 52 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01681199
|Cardiology department ,Beijing Anzhen hospital||Recruiting|
|Beijing, Beijing, China, 100029|
|Contact: Xin Du, PhD 86 15010519643 firstname.lastname@example.org|
|Sub-Investigator: Xin Du, PhD|