A High-Resolution Magnetic Resonance Imaging Study to Evaluate the Effect of Rosuvastatin on Carotid Atherosclerotic Plaques

NCT ID: NCT02305862

Last Updated: 2016-07-21

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

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-07-31

Brief Summary

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The aim of this study is to assess whether high intensive statin therapy could regress carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic Resonance imaging (CE-MRI).

Enrolled patients have a baseline CE-MRI examination for screening carotid atherosclerotic plaques and are randomized to either low dose of Rosuvastatin (5mg) group or high dose of Rosuvastatin (20mg) group. After 26 weeks, all patients received CE-MRI examination again and each pair of baseline and follow-up CE-MRI assessments was analyzed in a blinded fashion. Moreover, lipid level and major adverse cardiovascular events are also evaluated during follow-up.

Detailed Description

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Conditions

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Arteriosclerosis Diabetes Mellitus Lipid Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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low dose group (5mg)

low dose Rosuvastatin

Group Type EXPERIMENTAL

Rosuvastatin 5mg

Intervention Type DRUG

drug intervention

high dose group (20mg)

high dose Rosuvastatin

Group Type EXPERIMENTAL

Rosuvastatin 20mg

Intervention Type DRUG

drug intervention

Interventions

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Rosuvastatin 5mg

drug intervention

Intervention Type DRUG

Rosuvastatin 20mg

drug intervention

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-Patients with coronary artery disease or carotid atherosclerotic plaque or hyperlipideimia or old myocardial infarction

Exclusion Criteria

* Planning coronary stenting
* Heart failure
* Uncontrolled hypertension(≥200/110mmHg)
* Uncontrolled diabetes mellitus (HbA1C≥9.5%)
* Hepatic insufficiency
* Renal dysfunction
* Cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Buxing Chen

Director of department of cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Buxing Chen, MD, Ph.D

Role: CONTACT

861067096572

Facility Contacts

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Qiang Fu, Dr

Role: primary

861067096562

Other Identifiers

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AMARIROCAP

Identifier Type: -

Identifier Source: org_study_id

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