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

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ClinicalTrials.gov Identifier: NCT00674297
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

May 5, 2008
May 7, 2008
April 21, 2017
May 1, 2018
May 1, 2018
May 2008
July 2011   (Final data collection date for primary outcome measure)
  • Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients [ Time Frame: 3 months ]
    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 [ Time Frame: 3 months ]
    Biomarker sTF (pM)
  • Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients [ Time Frame: 3 months ]
    Biomarkers sICAM-1 (ng/mL), sVCAM-1 (ng/mL), sE-sel (ng/mL)
Pro-inflammatory and prothrombotic markers [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00674297 on ClinicalTrials.gov Archive Site
Not Provided
Safety of fluvastatin in antiphospholipid antibody-positive patients [ Time Frame: 3 months ]
Not Provided
Not Provided
 
Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
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).

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Antiphospholipid Syndrome
Drug: Fluvastatin
Fluvastatin 40 mg daily for 3 months
Other Name: Lescol, Lescol XL
Experimental: Fluvastatin
All patients will take Fluvastatin 40 mg daily for 3 months.
Intervention: Drug: Fluvastatin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
60
February 2013
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00674297
IRB 28005
Yes
Not Provided
Plan to Share IPD: No
Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
University of Texas
Principal Investigator: Doruk Erkan, MD Hospital for Special Surgery, New York
Principal Investigator: Silvia Pierangeli, PhD University of Texas
Hospital for Special Surgery, New York
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP