Phase 2
N=41
Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
Antiphospholipid Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00674297 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients — 31.2; 12.2; 0.4; 2.7 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients |
281.6; 55.1; 163.5; 2.8; 1128.4; 156.4 | — |
| PRIMARY Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients |
281.6; 55.1; 163.5; 2.8; 1128.4; 156.4 | — |
| PRIMARY Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients |
281.6; 55.1; 163.5; 2.8; 1128.4; 156.4 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00674297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.