NCT02420899

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

April 13, 2015

Last Update Submit

June 6, 2015

Conditions

Acute Coronary Syndrome

Keywords

IVUSACS

Outcome Measures

Primary Outcomes (1)

  • Percent Atheroma Volume (PAV)

    Percent Atheroma Volume

    36 weeks

Secondary Outcomes (1)

  • inflammatory marker levels

    36 weeks

Other Outcomes (3)

  • Total Atheroma Volume (TAV)

    36 weeks

  • lipid level

    36 weeks

  • safety and tolerability as assessed by blood biochemistry, blood routines and urine routines

    36 weeks

Study Arms (1)

Statins,lipid-lowering drugs

EXPERIMENTAL

rosuvastatin 10mg or 20mg per day，pro

Drug: rosuvastatin

Interventions

rosuvastatinDRUG

10mg/d or 20mg/d,po

Also known as: crestor
Statins,lipid-lowering drugs

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liu Qingbo

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hui Chen, doctor

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingbo Liu, master

CONTACT

135523288301035105896@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hui Chen,Director,Clinical Professor,Principal Investigator

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 20, 2015

Study Start

April 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations

CN(1)