search
Back to results

Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus

Primary Purpose

Atherosclerosis, Thromboembolism, Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Rosuvastatin
placebo
aspirin
placebo
Sponsored by
Tuen Mun Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring lupus, atherosclerosis, thrombosis, statin, lipid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age > 18 years
  2. Fulfillment of at least 4 of the American College of Rheumatology (ACR) criteria for SLE

  3. 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
  4. Informed consent obtained

Exclusion Criteria:

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

Sites / Locations

  • Tuen Mun Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

treatment arm 1

Treatment arm 2

treatment arm 3

treatment arm 4

Arm Description

aspirin

placebo

Outcomes

Primary Outcome Measures

endothelial activation markers

Secondary Outcome Measures

carotid intima media thickness
coronary Agatston score
Thrombotic events
adverse events

Full Information

First Posted
September 1, 2006
Last Updated
September 15, 2010
Sponsor
Tuen Mun Hospital
Collaborators
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00371501
Brief Title
Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus
Official Title
Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tuen Mun Hospital
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
To study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus. Subclinical atherosclerosis is assessed by ultrasound study of the carotid vessels and CT scan of the coronary arteries for calcium scores. Blood markers of endothelial activation will also be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Thromboembolism, Systemic Lupus Erythematosus
Keywords
lupus, atherosclerosis, thrombosis, statin, lipid

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment arm 1
Arm Type
Active Comparator
Arm Title
Treatment arm 2
Arm Type
Placebo Comparator
Arm Title
treatment arm 3
Arm Type
Active Comparator
Arm Description
aspirin
Arm Title
treatment arm 4
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
10mg/day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
one tablet/day
Intervention Type
Drug
Intervention Name(s)
aspirin
Intervention Description
80mg/day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
endothelial activation markers
Time Frame
12 months
Secondary Outcome Measure Information:
Title
carotid intima media thickness
Time Frame
24 months
Title
coronary Agatston score
Time Frame
60 months
Title
Thrombotic events
Time Frame
60 months
Title
adverse events
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CC Mok, MD, FRCP
Organizational Affiliation
Department of Medicine, Tuen Mun Hospital, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
21309005
Citation
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.
Results Reference
derived

Learn more about this trial

Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus

We'll reach out to this number within 24 hrs