FAITH: Fluvastatin AmelIorates aTHerosclerosis Study

• Sponsor: Beijing Anzhen Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01681199
• Collaborator: Novartis (Industry)
• Enrollment: 140
• Location: 1
• Arm: 1
• Duration (Months): 25
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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 .

Study Design

• Study Type: Interventional
• Anticipated 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: Jul 1, 2012
• Anticipated Primary Completion Date: Apr 1, 2014
• Anticipated Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluvastatin extended release tablet Fluvastatin extended release tablet 80mg/day	Drug: Fluvastatin extended release tablet; Other Names: Lescol XL

Outcome Measures

Primary Outcome Measures

1. carotid IMT [1 year]

Secondary Outcome Measures

1. lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I [week 12 and 24]

Other Outcome Measures

1. hs-CRP, Lp-PLA2, OPN and OPG. [week 12,24 and 52]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 70 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology department ,Beijing Anzhen hospital	Beijing	Beijing	China	100029

Sponsors and Collaborators

• Beijing Anzhen Hospital
• Novartis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang sheng Ma, director of cardiology department, Beijing Anzhen Hospital
• ClinicalTrials.gov Identifier: NCT01681199
• Other Study ID Numbers: AZYY-XNK-2012001
• First Posted: Sep 7, 2012
• Last Update Posted: Sep 7, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by Chang sheng Ma, director of cardiology department, Beijing Anzhen Hospital: statin; atherosclerosis; Coronary heart disease; OPN; OPG
• Additional relevant MeSH terms: Heart Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia

Study Results

No Results Posted as of Sep 7, 2012