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Completed

NCT Number: NCT00371501

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

10mg/day

Other names: Crestor

Placebo

Drug

one tablet/day

Aspirin

Drug

80mg/day

Primary outcomes

  1. endothelial activation markers

    Time frame: 12 months

Secondary outcomes

  1. carotid intima media thickness

    Time frame: 24 months

  2. coronary Agatston score

    Time frame: 60 months

  3. Thrombotic events

    Time frame: 60 months

  4. adverse events

    Time frame: 60 months

Sponsors and collaborators

Lead sponsor

Tuen Mun Hospital

Other Gov

Collaborators

  • AstraZeneca

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 4, 2006
Registry last updated
Sep 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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