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

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).

Study Overview

• Status: Completed
• Conditions: Antiphospholipid Syndrome
• Intervention / Treatment: Drug: Fluvastatin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
  • Texas
    • Galveston, Texas, United States, 77555
      • Division of Rheumatology, University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluvastatin; All patients will take Fluvastatin 40 mg daily for 3 months.	Drug: Fluvastatin; Fluvastatin 40 mg daily for 3 months; Other Names: Lescol, Lescol XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients	Biomarkers: IL6 (pg/mL), IL1β (pg/mL), IL8 (pg/mL), VEGF (pg/mL), TNFα (pg/mL), IFNα (pg/mL), IP10 (pg/mL), sCD40L (pg/mL)	3 months
Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients	Biomarker sTF (pM)	3 months
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

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Collaborators: University of Texas
• Investigators: Principal Investigator: Doruk Erkan, MD, Hospital for Special Surgery, New York; Principal Investigator: Silvia Pierangeli, PhD, University of Texas

Publications and helpful links

General Publications

• Erkan D, Willis R, Murthy VL, Basra G, Vega J, Ruiz-Limon P, Carrera AL, Papalardo E, Martinez-Martinez LA, Gonzalez 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: May 5, 2008
• First Submitted That Met QC Criteria: May 6, 2008
• First Posted (Estimate): May 7, 2008

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: March 29, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Persistently Antiphospholipid Antibody Positive Patients
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease; Syndrome; Antiphospholipid Syndrome
• Other Study ID Numbers: IRB 28005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO