NCT00371501

Brief Summary

The purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus (SLE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 16, 2010

Status Verified

September 1, 2010

Enrollment Period

3.5 years

First QC Date

September 1, 2006

Last Update Submit

September 15, 2010

Conditions

AtherosclerosisThromboembolismSystemic Lupus Erythematosus

Keywords

lupusatherosclerosisthrombosisstatinlipid

Outcome Measures

Primary Outcomes (1)

  • endothelial activation markers

    12 months

Secondary Outcomes (4)

  • carotid intima media thickness

    24 months

  • coronary Agatston score

    60 months

  • Thrombotic events

    60 months

  • adverse events

    60 months

Study Arms (4)

treatment arm 1

ACTIVE COMPARATOR
Drug: Rosuvastatin

Treatment arm 2

PLACEBO COMPARATOR
Drug: placebo

treatment arm 3

ACTIVE COMPARATOR

aspirin

Drug: aspirin

treatment arm 4

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

RosuvastatinDRUG

10mg/day

Also known as: Crestor
treatment arm 1
placeboDRUG

one tablet/day

Treatment arm 2
aspirinDRUG

80mg/day

treatment arm 3

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years
  • Fulfillment of at least 4 of the American College of Rheumatology (ACR) criteria for SLE
  • Presence of any two of the following risk factors:
  • SLE duration of \>= 5 years
  • Postmenopausal
  • Age \>= 40 years
  • Diabetes mellitus
  • Hypertension (140/90 mmHg)
  • Serum low density lipoprotein (LDL) level \>= 2.6 mmol/L or total cholesterol \>= 5.5 mmol/L
  • Obesity (body mass index \>= 27 kg/m2)
  • Chronic current smoker
  • Positive antiphospholipid antibodies
  • Renal function impairment
  • Persistent proteinuria \>= 1 gm/day for \>= 6 months
  • Informed consent obtained

You may not qualify if:

  • Patients with known allergy to aspirin, or any other non-steroidal anti-inflammatory drugs (NSAIDs), or statins
  • Patient with a history of severe gastrointestinal intolerance to aspirin (e.g., gastrointestinal bleeding) or other NSAIDs
  • Patients with history of arterial or venous thromboembolism
  • Patients receiving aspirin or other anti-platelet agents
  • Patients receiving long-term non-aspirin NSAIDs
  • Patients receiving anticoagulation therapy (e.g., warfarin)
  • Patients with history of intolerance or allergy to the statins
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuen Mun Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Mok CC, Wong CK, To CH, Lai JP, Lam CS. Effects of rosuvastatin on vascular biomarkers and carotid atherosclerosis in lupus: a randomized, double-blind, placebo-controlled trial. Arthritis Care Res (Hoboken). 2011 Jun;63(6):875-83. doi: 10.1002/acr.20440.

    PMID: 21309005DERIVED

MeSH Terms

Conditions

AtherosclerosisThromboembolismLupus Erythematosus, SystemicThrombosis

Interventions

Rosuvastatin CalciumAspirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • CC Mok, MD, FRCP

    Department of Medicine, Tuen Mun Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 1, 2006

First Posted

September 4, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 16, 2010

Record last verified: 2010-09

Locations

HK(1)