NCT02548936

Brief Summary

This is a randomized single-blind trial. This study aimed to determine if intensive lipid-lowering therapy (simvastatin-ezetimibe combination therapy) could reduce the progression of atherosclerosis effectively and safely among SLE patients with carotid artery intima thickening. The study results were expected to be helpful for SLE patients in preventing atherosclerosis.

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
30

participants targeted

Target at P50-P75 for early_phase_1

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
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 14, 2015

Status Verified

August 1, 2015

Enrollment Period

1.5 years

First QC Date

August 31, 2015

Last Update Submit

September 11, 2015

Conditions

Atherosclerosis

Keywords

Cholesterol, LDLCarotid Intima-Media ThicknessAtherosclerosisEzetimibe, Simvastatin Drug CombinationLupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

  • The change of carotid intima media thickness over 12 months

    CIMT(Unit: millimeter) is defined as the distance between the lumen-intima interface and the media-adventitia interface, which corresponded to the inner and outer echogenic lines seen on the B-mode ultrasound image.

    baseline, 12 months

Secondary Outcomes (8)

  • The rate of abnormal elevated alanine aminotransferase (ALT)

    1 month

  • The rate of abnormal elevated alanine aminotransferase

    3 months

  • The rate of abnormal elevated alanine aminotransferase

    6 months

  • The rate of abnormal elevated alanine aminotransferase

    12 months

  • The rate of abnormal elevated creatine kinase (CK)

    1 month

  • +3 more secondary outcomes

Study Arms (2)

Lipid-lowering treatment

EXPERIMENTAL

The Lipid-lowering treatment is Ezetimibe+Simvastatin Drug Combination by oral administration. The patients in intervention group received simvastatin (10mg/day) + ezetimibe (20 mg/day) combined therapy for 12 month.

Drug: Ezetimibe+Simvastatin Drug Combination

No lipid-lowering treatment

NO INTERVENTION

Without any Lipid-lowering treatment for 12 month.

Interventions

Ezetimibe+Simvastatin Drug CombinationDRUG

The patients in Ezetimibe+Simvastatin Drug Combination group received simvastatin (10mg/day) + ezetimibe (20 mg/day) by oral administration for 12 month.

Also known as: ezetimibe/simvastatin
Lipid-lowering treatment

Eligibility Criteria

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

You may qualify if:

  • age ≥18 years and clinical diagnosis of SLE
  • abnormal CIMT (≥0.9 mm at any site) by B-mode ultrasound
  • LDL-C≥100mg/dl
  • a signed written informed consent was able to be obtained.

You may not qualify if:

  • atherosclerotic cardiovascular disease
  • diabetes
  • history of intolerance or allergy to the statins or ezetimibe
  • had ever received statins or ezetimibe within 12 months of study entry
  • LDL-C≥190mg/dl
  • active infection
  • ALT was higher than 2 times of the upper normal limit or CK was higher than 1.5 times of the upper normal limit.
  • pregnant or lactating women
  • patients with severe SLE.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

AtherosclerosisLupus Erythematosus, Systemic

Interventions

Ezetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SimvastatinLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEzetimibeAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Shuyang Zhang, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 14, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

September 14, 2015

Record last verified: 2015-08

Locations

CN(1)