NCT00674297

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2008

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

May 1, 2018

Completed
Last Updated

May 1, 2018

Status Verified

March 1, 2018

Enrollment Period

3.2 years

First QC Date

May 5, 2008

Results QC Date

April 21, 2017

Last Update Submit

March 29, 2018

Conditions

Antiphospholipid Syndrome

Keywords

Persistently Antiphospholipid Antibody Positive Patients

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Fluvastatin

EXPERIMENTAL

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

Drug: Fluvastatin

Interventions

FluvastatinDRUG

Fluvastatin 40 mg daily for 3 months

Also known as: Lescol, Lescol XL
Fluvastatin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Division of Rheumatology, University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

  • 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.

    PMID: 23933625BACKGROUND

Related Links

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Doruk Erkan, MD
Organization
Hospital for Special Surgery
erkand@hss.edu
212 774-2291

Study Officials

  • Doruk Erkan, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

  • Silvia Pierangeli, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 7, 2008

Study Start

May 1, 2008

Primary Completion

July 1, 2011

Study Completion

February 1, 2013

Last Updated

May 1, 2018

Results First Posted

May 1, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)