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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
  Purpose

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 Intervention Phase
Coronary Heart Disease
Atherosclerosis
 Drug: Fluvastatin extended release tablet
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Anzhen Hospital:

Primary Outcome Measures:
  • carotid IMT [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I [ Time Frame: week 12 and 24 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • hs-CRP, Lp-PLA2, OPN and OPG. [ Time Frame: week 12,24 and 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluvastatin extended release tablet
Fluvastatin extended release tablet 80mg/day
 Drug: Fluvastatin extended release tablet
Other Name: Lescol XL

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 .

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681199

Locations
China, Beijing
Cardiology department ,Beijing Anzhen hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Xin Du, PhD     86 15010519643     duxinheart@sina.com    
Sub-Investigator: Xin Du, PhD            
Sponsors and Collaborators
Beijing Anzhen Hospital
Novartis
  More Information

No publications provided

Responsible Party: Chang sheng Ma, director of cardiology department, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT01681199     History of Changes
Other Study ID Numbers: AZYY-XNK-2012001
Study First Received: September 5, 2012
Last Updated: September 5, 2012
Health Authority: China: Ethics Committee

Keywords provided by Beijing Anzhen Hospital:
statin
atherosclerosis
Coronary heart disease
OPN
OPG

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Fluvastatin
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013