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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00674297
Other study ID # IRB 28005
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2008
Est. completion date February 2013

Study information

Verified date March 2018
Source Hospital for Special Surgery, New York
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date February 2013
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Persistently antiphospholipid-antibody positive patients (positive lupus anticoagulant test, anticardiolipin antibody = 40 GPL /MPL, and/or anti- ß2-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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fluvastatin
Fluvastatin 40 mg daily for 3 months

Locations

Country Name City State
United States Division of Rheumatology, University of Texas Medical Branch Galveston Texas
United States Hospital for Special Surgery New York New York

Sponsors (2)

Lead Sponsor Collaborator
Hospital for Special Surgery, New York University of Texas

Country where clinical trial is conducted

United States, 

References & Publications (1)

Erkan D, Willis R, Murthy VL, Basra G, Vega J, Ruiz-Limón P, Carrera AL, Papalardo E, Martínez-Martínez LA, González EB, Pierangeli SS. A prospective open-label pilot study of fluvastatin on proinflammatory and prothrombotic biomarkers in antiphospholipid antibody positive patients. Ann Rheum Dis. 2014 Jun;73(6):1176-80. doi: 10.1136/annrheumdis-2013-203622. Epub 2013 Aug 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients Biomarkers: IL6 (pg/mL), IL1ß (pg/mL), IL8 (pg/mL), VEGF (pg/mL), TNFa (pg/mL), IFNa (pg/mL), IP10 (pg/mL), sCD40L (pg/mL) 3 months
Primary Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients Biomarker sTF (pM) 3 months
Primary Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients Biomarkers sICAM-1 (ng/mL), sVCAM-1 (ng/mL), sE-sel (ng/mL) 3 months
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