Different Doses of Rosuvastatin Therapy on Regression of... | NCT02420899

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

NCT02420899

Sponsor

Beijing Friendship Hospital

Status

Unknown status

Last Update Posted

Jun 9, 2015Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Acute Coronary Syndrome

Interventions

rosuvastatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Jul 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Apr 13, 2015

First Submission Date that Met QC Criteria

Apr 17, 2015

First Posted Date

Apr 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2015

Last Update Posted Date

Jun 9, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hui Chen, Hui Chen,Director,Clinical Professor,Principal Investigator, Beijing Friendship HospitalPrincipal Investigator

Lead Sponsor

Beijing Friendship HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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:

Provision of informed consent prior to any study specific procedures
18 to 75 years old ACS patients, male or female
The angiographic luminal diameter narrowing in any non-culprit site is between 40%-70%
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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Statins,lipid-lowering drugs	Experimental	rosuvastatin 10mg or 20mg per day，pro	Drug: rosuvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rosuvastatin	Drug	10mg/d or 20mg/d,po	Statins,lipid-lowering drugs

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Total Atheroma Volume (TAV)	Total Atheroma Volume	36 weeks
lipid level	LDL-C,HDL-C,TC,TG	36 weeks

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qingbo Liu, master	Contact	13552328830		1035105896@qq.com

Overall Officials

Name	Affiliation	Role
Hui Chen, doctor	Beijing Friendship Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Liu Qingbo	Recruiting	Beijing	Beijing Municipality	100050	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes