Different Doses of Rosuvastatin Therapy on Regression of Critical Coronary Atherosclerosis in ACS Patients

Effect of Different Doses of Rosuvastatin Therapy on Regression of Critical Coronary Atherosclerosis in Chinese ACS Patients

The purpose of this study is to determine whether Rosuvastatin 10mg/d or 20mg/d for 36 weeks can regress critical coronary atherosclerosis as determined by IVUS imaging in Chinese Acute Coronary Syndrome (ACS) patients.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: rosuvastatin

Detailed Description

This is a prospective, open-label, parallel group study to evaluate the efficacy of rosuvastatin 10mg/d or 20mg/d on critical coronary atherosclerosis in Chinese ACS patients. The anticipated duration of the study is approximately 36 weeks, Patients with angiographic luminal diameter narrowing in any non-culprit site between 40%-70% will be enrolled from the study site. The primary efficacy parameter is the percent change of Total Atheroma Volume (TAV) of critical coronary atherosclerosis after 36 weeks of treatment.

For inclusion in the study subjects should fulfill the following criteria:

1. Provision of informed consent prior to any study specific procedures
2. 18 to 75 years old ACS patients, male or female
3. The angiographic luminal diameter narrowing in any non-culprit site is between 40%-70%
4. statin-naive, defined as receiving no statin therapy within 3 monthsThe primary efficacy variable of the study is percent change of TAV from baseline after rosuvastatin 10mg/d or 20mg/d for 36 weeks as determined by IVUS imaging.

The secondary efficacy variables are:

• Change of blood lipid level from baseline at 12th, 24th, 36nd week
• Change of inflammatory markers from baseline at 36nd week
• Change of Percent Atheroma Volume (PAV) as determined by IVUS imaging at 36nd week

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Liu Qingbo
      • Contact: Qingbo Liu, master; Phone Number: 13552328830; Email: 1035105896@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1.Provision of informed consent prior to any study specific procedures; 2.18 to 75 years old ACS patients, male or female; 3.The angiographic luminal diameter narrowing in any non-culprit site is between 40%-70%; 4.statin-naive, defined as receiving no statin therapy within 3 months;

Exclusion Criteria:

1. Have received statin therapy within 3 months;
2. The angiographic luminal diameter narrowing in any coronary vessels is more than 70%;
3. Active liver disease, ALT≥3*ULN;
4. Renal function damage, CrCl<30ml/min;
5. Myopathy;
6. Pregnancy, lactation female;
7. Using cyclosporine;
8. Patients with uncontrolled triglyceride levels TG≥5.65 mmol／L;
9. Poorly controlled diabetes (HbA1c≥10%）Hypersensitivity to rosuvastatin or any of the recipients.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Statins,lipid-lowering drugs; rosuvastatin 10mg or 20mg per day，pro	Drug: rosuvastatin; 10mg/d or 20mg/d,po; Other Names: crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Atheroma Volume (PAV)	Percent Atheroma Volume	36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammatory marker levels	MCP-1, VCAM-1 level and mRNA level of ICAM-1, CCR2	36 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Atheroma Volume (TAV)	Total Atheroma Volume	36 weeks
lipid level	LDL-C,HDL-C,TC,TG	36 weeks
safety and tolerability as assessed by blood biochemistry, blood routines and urine routines	blood biochemistry, blood routines and urine routines	36 weeks

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Hui Chen, doctor, Beijing Friendship Hospital

Publications and helpful links

General Publications

• 1.Liao J K, Laufs U. Pleiotropic effects of statins[J]. Annual review of pharmacology and toxicology, 2005, 45: 89. 2.Davignon J. Beneficial cardiovascular pleiotropic effects of statins[J]. Circulation, 2004, 109(23 suppl 1): III-39-III-43. 3.Falk E, Shah P K, Fuster V. Coronary plaque disruption[J]. Circulation, 1995, 92(3): 657-671. 4. Nissen SE, Nicholls SJ, Sipahi I, et al.Effect of very high-intensity statin therapy on regression of coronary atherosclerosis:the ASTEROID trial. JAMA, 2006; 295: 1556-65. 5. Lee CW, et al. Comparison of Effects of Atorvastatin(20mg) Versus Rosuvastatin(10mg) Therapy on Mild Coronary Atherosclerosis Plaques(from the ARTMAP Trial).Am J Cardiol, 2012; 109:1700-1704.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: April 13, 2015
• First Submitted That Met QC Criteria: April 17, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Estimate): June 9, 2015
• Last Update Submitted That Met QC Criteria: June 6, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: IVUS; ACS
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: 40068860-9