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

Primary Purpose

Antiphospholipid Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluvastatin
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Antiphospholipid Syndrome focused on measuring Persistently Antiphospholipid Antibody Positive Patients

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Special Surgery
  • Division of Rheumatology, University of Texas Medical Branch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluvastatin

Arm Description

All patients will take Fluvastatin 40 mg daily for 3 months.

Outcomes

Primary Outcome Measures

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)
Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients
Biomarker sTF (pM)
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)

Secondary Outcome Measures

Full Information

First Posted
May 5, 2008
Last Updated
March 29, 2018
Sponsor
Hospital for Special Surgery, New York
Collaborators
University of Texas
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1. Study Identification

Unique Protocol Identification Number
NCT00674297
Brief Title
Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
Official Title
Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
University of Texas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antiphospholipid Syndrome
Keywords
Persistently Antiphospholipid Antibody Positive Patients

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluvastatin
Arm Type
Experimental
Arm Description
All patients will take Fluvastatin 40 mg daily for 3 months.
Intervention Type
Drug
Intervention Name(s)
Fluvastatin
Other Intervention Name(s)
Lescol, Lescol XL
Intervention Description
Fluvastatin 40 mg daily for 3 months
Primary Outcome Measure Information:
Title
Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients
Description
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)
Time Frame
3 months
Title
Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients
Description
Biomarker sTF (pM)
Time Frame
3 months
Title
Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients
Description
Biomarkers sICAM-1 (ng/mL), sVCAM-1 (ng/mL), sE-sel (ng/mL)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doruk Erkan, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silvia Pierangeli, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Division of Rheumatology, University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23933625
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23933625
Description
A prospective open-label pilot study of fluvastatin on proinflammatory and prothrombotic biomarkers in antiphospholipid antibody positive patients

Learn more about this trial

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

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