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Fluvastatin AmelIorates aTHerosclerosis Study

NCT ID: NCT01681199

Last Updated: 2012-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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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 .

Conditions

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Coronary Heart Disease Atherosclerosis

Keywords

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statin atherosclerosis Coronary heart disease OPN OPG

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fluvastatin extended release tablet

Fluvastatin extended release tablet 80mg/day

Group Type EXPERIMENTAL

Fluvastatin extended release tablet

Intervention Type DRUG

Interventions

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Fluvastatin extended release tablet

Intervention Type DRUG

Other Intervention Names

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Lescol XL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang sheng Ma

director of cardiology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cardiology department ,Beijing Anzhen hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xin Du, PhD

Role: primary

Other Identifiers

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AZYY-XNK-2012001

Identifier Type: -

Identifier Source: org_study_id