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

Capital Medical University

Status: Unknown

Conditions: Lipid Disorder; Diabetes Mellitus; Arteriosclerosis

Treatments: Drug: Rosuvastatin 5mg; Drug: Rosuvastatin 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02305862

AMARIROCAP

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

low dose group (5mg)

Experimental group

Description:

low dose Rosuvastatin

Treatment:

Drug: Rosuvastatin 5mg

high dose group (20mg)

Experimental group

Description:

high dose Rosuvastatin

Treatment:

Drug: Rosuvastatin 20mg