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

This study has been completed.

Sponsor:

Collaborator:

AstraZeneca

Information provided by:

Tuen Mun Hospital

ClinicalTrials.gov Identifier:

NCT00371501

First received: September 1, 2006

Last updated: September 15, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 1, 2006

Last Updated Date

September 15, 2010

Start Date ^ICMJE

June 2006

Primary Completion Date

December 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

endothelial activation markers [ Time Frame: 12 months ]

Original Primary Outcome Measures ^ICMJE

intimal thickness of carotid artery
coronary calcium scores
endothelial activation markers

Change History

Complete list of historical versions of study NCT00371501 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

carotid intima media thickness [ Time Frame: 24 months ]
coronary Agatston score [ Time Frame: 60 months ]
Thrombotic events [ Time Frame: 60 months ]
adverse events [ Time Frame: 60 months ]

Original Secondary Outcome Measures ^ICMJE

clinical thromboembolic events

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Atherosclerosis
Thromboembolism
Systemic Lupus Erythematosus

Intervention ^ICMJE

Drug: Rosuvastatin
10mg/day

Other Name: Crestor
Drug: placebo
one tablet/day
Drug: aspirin
80mg/day
Drug: placebo
placebo

Study Arms

Active Comparator: treatment arm 1
Intervention: Drug: Rosuvastatin
Placebo Comparator: Treatment arm 2
Intervention: Drug: placebo
Active Comparator: treatment arm 3
aspirin

Intervention: Drug: aspirin
Placebo Comparator: treatment arm 4
placebo

Intervention: Drug: placebo

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2009

Primary Completion Date

December 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Hong Kong

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00371501

Other Study ID Numbers ^ICMJE

HARECCTR0500059

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

CC Mok, Tuen Mun Hospital, Hong Kong

Study Sponsor ^ICMJE

Tuen Mun Hospital

Collaborators ^ICMJE

AstraZeneca

Investigators ^ICMJE

Principal Investigator:

CC Mok, MD, FRCP

Department of Medicine, Tuen Mun Hospital, Hong Kong

PRS Account

Tuen Mun Hospital

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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