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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm 1 | Active Comparator |
| |
| Treatment arm 2 | Placebo Comparator |
| |
| treatment arm 3 | Active Comparator | aspirin |
|
| treatment arm 4 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 10mg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| endothelial activation markers | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| carotid intima media thickness | 24 months | |
| coronary Agatston score | 60 months | |
| Thrombotic events |
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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:
Informed consent obtained
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CC Mok, MD, FRCP | Department of Medicine, Tuen Mun Hospital, Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tuen Mun Hospital | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21309005 | Derived | 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. |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D013923 | Thromboembolism |
| D008180 | Lupus Erythematosus, Systemic |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| placebo |
| Drug |
one tablet/day |
|
| aspirin | Drug | 80mg/day |
|
| placebo | Drug | placebo |
|
| 60 months |
| adverse events | 60 months |
| D016769 |
| Embolism and Thrombosis |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |