Fluvastatin AmelIorates aTHerosclerosis Study (FAITH)

September 5, 2012 updated by: Chang sheng Ma, Beijing Anzhen Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Cardiology department ,Beijing Anzhen hospital
        • Contact:
        • Sub-Investigator:
          • Xin Du, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
carotid IMT
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I
Time Frame: week 12 and 24
week 12 and 24

Other Outcome Measures

Outcome Measure
Time Frame
hs-CRP, Lp-PLA2, OPN and OPG.
Time Frame: week 12,24 and 52
week 12,24 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Collaborators

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (Estimate)

September 7, 2012

Study Record Updates

Last Update Posted (Estimate)

September 7, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZYY-XNK-2012001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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