DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Capital Medical University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arteriosclerosis; Diabetes Mellitus; Lipid Disorder

Intervention: Rosuvastatin 5mg (Drug); Rosuvastatin 20mg (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Capital Medical University

Overall contact:
Buxing Chen, MD, Ph.D, Phone: 861067096572, Email: chbux@126.com

Summary

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.

Clinical Details

Official title: An Open-label, Single-centre Randomized Study Evaluating the Effect of Treatment With Rosuvastatin 5/20mg on Atherosclerotic Disease as Measured by High-Resolution Contrast Enhanced Magnetic Resonance Imaging in Patients With Coronary Artery Disease and Hyperlipideimia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI

Secondary outcome:

major adverse cardiovascular events

To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.

To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks

To evaluate the change from baseline in renal function (serum creatine) at 26 weeks

To evaluate the change from baseline in creatine kinase at 26 weeks

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Buxing Chen, MD, Ph.D, Phone: 861067096572, Email: chbux@126.com

Beijing Tiantan Hospital, Capital Medical University, Beijing 100050, China; Recruiting
Qiang Fu, Dr, Phone: 861067096562, Email: fuqiang66882000@hotmail.com
Buxing Chen, Dr, Principal Investigator
Additional Information

Starting date: January 2013
Last updated: July 27, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017