Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients

Antiphospholipid Syndrome Clinical Trial

Official title:

Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674297
• Other study ID #: IRB 28005
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Syndrome

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

External Links

•   A prospective open-label pilot study of fluvastatin on proinflammatory and prothrombotic biomarkers in antiphospholipid antibody positive patients