ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Antiphospholipid Syndrome
Intervention Drug: Fluvastatin
Enrollment 41
Recruitment Details 4 groups were recruited: primary antiphospholipid syndrome(PAPS); systemic lupus erythematosus (SLE) with antiphospholipid syndrome(APS)(SLE/APS); persistent aPL positivity without SLE/APS(Primary aPL); and persistent aPL positivity with SLE but no APS(SLE/ aPL). The frequency-matched control group was identified from a databank of healthy persons.
Pre-assignment Details

SLE was defined based on the American College of Rheumatology classification criteria. APS was defined based on the updated Sapporo classification criteria.

Positive aPL was defined as persistently (at least 12 weeks apart) positive LA test, aCL≥40 GPL/MPL and/or aβ2GPI≥20 SGU/SMU.

Arm/Group Title PAPS SLE/APS Primary aPL SLE/aPL
Hide Arm/Group Description Primary APS SLE with APS Persistant aPL positivity without SLE or APS. Persistent aPL positivity with SLE but no APS.
Period Title: Overall Study
Started [1] 18 7 9 7
Completed [2] 8 7 5 4
Not Completed 10 0 4 3
[1]
41 patients recruited.
[2]
24 patients completed the study.
Arm/Group Title Fluvastatin
Hide Arm/Group Description

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

Fluvastatin: Fluvastatin 40 mg daily for 3 months

Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
<=18 years 0
Between 18 and 65 years 41
>=65 years 0
[1]
Measure Description: Ages between 18 and 65
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
31
  75.6%
Male
10
  24.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Caucasian Number Analyzed 41 participants
28
  68.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants
41
1.Primary Outcome
Title Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PAPS SLE/APS Primary aPL SLE/aPL
Hide Arm/Group Description:
Primary APS
SLE with APS
Persistant aPL positivity without SLE or APS.
Persistent aPL positivity with SLE but no APS.
Overall Number of Participants Analyzed 18 7 9 7
Mean (Standard Deviation)
Unit of Measure: pg/mL
Biomarker IL6 31.2  (48.4) 12.2  (103.5) 0.4  (0.7) 2.7  (76.8)
Biomarker IL1B 3.0  (7.7) 11.4  (20.1) 0.3  (0.6) 0.5  (5.1)
Biomarker IL8 24.5  (48.4) 27.4  (53.7) 7.2  (50.4) 21.6  (48.9)
Biomarker VEGF 242.2  (399.6) 109.1  (348.4) 74.6  (158.3) 67.2  (499.4)
Biomarker TNFa 21.5  (50.5) 11.6  (24.1) 8.9  (15.7) 53.9  (62.5)
Biomarker IFNa 10.1  (88.4) 0.3  (367.1) 0.3  (512.2) 13.2  (558.5)
Biomarker IP10 427.2  (569.8) 656.2  (454.8) 249.7  (698.9) 472.5  (690.5)
Biomarker sCD40L 276.5  (676.0) 145.6  (5159.8) 149.7  (17035.6) 76.9  (970.0)
2.Primary Outcome
Title Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients
Hide Description Biomarker sTF (pM)
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PAPS SLE/APS Primary aPL SLE/aPL
Hide Arm/Group Description:
Primary APS
SLE with APS
Persistant aPL positivity without SLE or APS.
Persistent aPL positivity with SLE but no APS.
Overall Number of Participants Analyzed 18 7 9 7
Mean (Standard Deviation)
Unit of Measure: pM
153.6  (381.0) 329.2  (447.0) 190.4  (139.0) 102.1  (177.0)
3.Primary Outcome
Title Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients
Hide Description Biomarkers sICAM-1 (ng/mL), sVCAM-1 (ng/mL), sE-sel (ng/mL)
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PAPS SLE/APS Primary aPL SLE/aPL
Hide Arm/Group Description:
Primary APS
SLE with APS
Persistant aPL positivity without SLE or APS.
Persistent aPL positivity with SLE but no APS.
Overall Number of Participants Analyzed 18 7 9 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
sICAM-1 281.6  (406.8) 55.1  (70.3) 163.5  (341.7) 2.8  (32.9)
sVCAM-1 1128.4  (1152.8) 156.4  (19.3) 321.3  (1015.1) 41.1  (27.2)
sE-sel 27.7  (36.7) 14.7  (20.4) 10.9  (26.4) 4.1  (21.5)
Time Frame 6 months
Adverse Event Reporting Description An adverse event (AE) was defined as any untoward medical occurrence in a study patient regardless of causality assessment. A serious AE was defined as one occurring at any dose that met one or more of the following criteria: death; life-threatening; requiring or prolonging inpatient hospitalisation; disabling; or resulting in a congenital anomaly/birth defect.
 
Arm/Group Title aPL Positive Patients
Hide Arm/Group Description Patients with aPL positivity
All-Cause Mortality
aPL Positive Patients
Affected / at Risk (%)
Total   0/41 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
aPL Positive Patients
Affected / at Risk (%) # Events
Total   0/41 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
aPL Positive Patients
Affected / at Risk (%) # Events
Total   8/41 (19.51%)    
Immune system disorders   
Lupus flare  1  1/41 (2.44%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/41 (2.44%)  1
Myalgia with high CPK  1  1/41 (2.44%)  1
Myalgia with normal CPK  1  3/41 (7.32%)  3
Nervous system disorders   
Headache  1  1/41 (2.44%)  1
Psychiatric disorders   
Insomnia  1  1/41 (2.44%)  1
Vascular disorders   
Recurrent deep vein thrombosis  1  1/41 (2.44%)  1
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Doruk Erkan, MD
Organization: Hospital for Special Surgery
Phone: 212 774-2291
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00674297     History of Changes
Other Study ID Numbers: IRB 28005
First Submitted: May 5, 2008
First Posted: May 7, 2008
Results First Submitted: April 21, 2017
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018