NCT01382277

Brief Summary

This multicentre, open-label, single-arm Study is to evaluate the effect of Rosuvastatin 20 mg 76 weeks on coronary atherosclerosis plaque versus baseline in Chinese coronary heart disease (CHD) patients with hyperlipidemia by measuring the plaque volume using a 64 slice spiral CT. Effect on blood lipids, hsCRP and Carotid intima-media thickness (CIMT) is also evaluated.

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
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2011

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

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

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

June 27, 2011

Status Verified

February 1, 2011

Enrollment Period

2.1 years

First QC Date

June 20, 2011

Last Update Submit

June 23, 2011

Conditions

HyperlipidemiaCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in coronary atherosclerosis plaque volume using a 64 slice spiral CT at 76 weeks

    76 weeks

Secondary Outcomes (8)

  • Change from baseline in blood lipids at 26 weeks

    26 weeks

  • Change from baseline in hsCRP at 26 weeks

    26 weeks

  • Change from baseline in Carotid intima-media thickness at 76 weeks

    76 weeks

  • Number of participants with adverse events and abnormal laboratory safety markers.

    76 weeks

  • Change from baseline in blood lipids at 52 weeks

    52 weeks

  • +3 more secondary outcomes

Study Arms (1)

Rosuvastatin 20 mg

EXPERIMENTAL

Rosuvastatin 20 mg for 76 weeks.

Drug: Rosuvastatin

Interventions

RosuvastatinDRUG

Rosuvastatin 20 mg per day for 76 weeks

Also known as: Crestor
Rosuvastatin 20 mg

Eligibility Criteria

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

You may qualify if:

  • Written informed consent
  • Men or women, aged 18 -75
  • Diagnosed with coronary heart disease (CHD) stable angina for more than 1 month and meet the following any one:
  • History of myocardial infarction.
  • CHD confirmed by coronary angiography.
  • Excercise ECG positive for CHD or perfusion defect
  • One or more main branch of coronary artery stenosis ≥ 50% confirmed by CT scanning.
  • Hyperlipidemia (lipid-lowering treatment naïve: LDL-C ≥130mg/dl, or having received lipid-lowering treatment: LDL-C ≥100mg/dl)
  • The 64 slice CT shows at least one significant coronary artery stenosis ≥20% with the narrowest ≤60% and meeting the following criteria:
  • Diameter of coronary artery lesion ≥2mm, length ≥5mm; distance between multiple lesions \>1cm
  • Plaque density \<100HU, no calcification
  • Vascular stenosis (20～60%) caused by plaques
  • Plaque thickness \>1mm
  • Plaque not in the coronary artery with previous PCI treatment.

You may not qualify if:

  • Acute myocardial infarction within 6 months
  • PCI or CABG therapy within 6 months
  • Anticipated PCI or CABG therapy in the following 3 months.
  • Tropnin I/Tropnin T higher than ULN
  • Cardiac failure NYHA III or above
  • Coronary artery left main stenosis \>50%
  • Emergency coronary angiography(CAG) is needed
  • Serious arrhythmia or tachycardia
  • Secondary hyperlipidemia
  • Familial hypercholestrolemia
  • Uncontrolled severe hypertension (≥200/110 mmHg)
  • Uncontrolled diabetes (HbA1c ≥9.5%)
  • Triglyceride ≥500 mg/dL (5.65 mmol/L)
  • Active hepatic disease or hepatic function impairment, ALT≥3ULN
  • Serum creatinine \>177 µmol/L (2.0 mg/dL)
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Division of Cardiology, Peking University First Hospital

Beijing, 100034, China

RECRUITING

MeSH Terms

Conditions

HyperlipidemiasCoronary Artery Disease

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Yong Huo, MD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Jiang, MD

CONTACT

86-10-66551383jiangjie@medmail.com.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2011

First Posted

June 27, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

June 27, 2011

Record last verified: 2011-02

Locations

CN(2)