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

NCT ID: NCT00371501

Last Updated: 2010-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Atherosclerosis Thromboembolism Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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treatment arm 1

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

10mg/day

Treatment arm 2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

one tablet/day

treatment arm 3

aspirin

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

80mg/day

treatment arm 4

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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Rosuvastatin

10mg/day

Intervention Type DRUG

placebo

one tablet/day

Intervention Type DRUG

aspirin

80mg/day

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Tuen Mun Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tuen Mun Hospital, Hong Kong

Principal Investigators

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CC Mok, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Tuen Mun Hospital, Hong Kong

Locations

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Tuen Mun Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type DERIVED
PMID: 21309005 (View on PubMed)

Other Identifiers

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HARECCTR0500059

Identifier Type: -

Identifier Source: org_study_id