Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/3/2018 |
| Start Date: | May 2008 |
| End Date: | February 2013 |
The purpose of this study is to determine whether a drug named Fluvastatin is beneficial and
safe in reducing the risk of cardiovascular disease and blood clots in patients with
antiphospholipid antibodies or Antiphospholipid Syndrome (APS).
safe in reducing the risk of cardiovascular disease and blood clots in patients with
antiphospholipid antibodies or Antiphospholipid Syndrome (APS).
The primary objective of the study is to determine the effects of fluvastatin on
pro-thrombotic and pro-inflammatory markers in aPL-positive lupus and non-lupus patients
(primary endpoint) and to determine the safety of fluvastatin in aPL-positive lupus and
non-lupus patients (secondary endpoint).
All eligible patients will sign an IRB-approved consent form during the screening visit and
give blood for baseline laboratory tests. Within a week of the screening visit, all patients
will be started on Fluvastatin 40 mg daily for three months. At three months patients will be
instructed to stop the study medication and they will be followed for another three months.
Thus, the total duration of the study is six months: first three months is interventional and
the last three months is observational.
pro-thrombotic and pro-inflammatory markers in aPL-positive lupus and non-lupus patients
(primary endpoint) and to determine the safety of fluvastatin in aPL-positive lupus and
non-lupus patients (secondary endpoint).
All eligible patients will sign an IRB-approved consent form during the screening visit and
give blood for baseline laboratory tests. Within a week of the screening visit, all patients
will be started on Fluvastatin 40 mg daily for three months. At three months patients will be
instructed to stop the study medication and they will be followed for another three months.
Thus, the total duration of the study is six months: first three months is interventional and
the last three months is observational.
Inclusion Criteria:
- Persistently antiphospholipid-antibody positive patients (positive lupus anticoagulant
test, anticardiolipin antibody ≥ 40 GPL /MPL, and/or anti- β2-glycoprotein I antibody
> 20 SGU/SMU) with or without systemic lupus erythematosus
Exclusion Criteria:
- Younger than 18 year-old
- Pregnant
- Planning to get pregnant within the next 6 months
- Taking other cholesterol lowering agents
- Taking other immunosuppressive medications (such as methotrexate, azathioprine,
cellcept, enbrel, remicade, or rituximab)(Hydroxychloroquine [Plaquenil] during the
study period is allowed).
- Treatment with biologic agents including anti-TNF medications and Rituximab
- Treatment with erythromycin, itraconazole, or clarithromycin
- Taking prednisone higher than 10 mg daily
- Taking non-steroidal anti-inflammatory drug (such as Motrin, Advil, etc) regularly
- Have a muscle or liver disease
- Have chronic renal disease requiring dialysis
- Have hepatitis C and/or HIV infection
- Have active infections requiring antibiotics
- Have the diagnosis of a systemic autoimmune disease (such as rheumatoid arthritis or
systemic sclerosis) other than lupus
- Have diagnosis of another chronic condition requiring corticosteroid treatment more
than 10mg daily
- History of an allergic reaction to cholesterol lowering agents
We found this trial at
2
sites
301 University Boulevard
Galveston, Texas 77555
Galveston, Texas 77555
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Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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