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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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Antiphospholipid Syndrome
Intervention: Drug: Fluvastatin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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.


Reporting Groups
  Description
PAPS Primary APS
SLE/APS SLE with APS
Primary aPL Persistant aPL positivity without SLE or APS.
SLE/aPL Persistent aPL positivity with SLE but no APS.

Participant Flow:   Overall Study
    PAPS   SLE/APS   Primary aPL   SLE/aPL
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.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fluvastatin

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

Fluvastatin: Fluvastatin 40 mg daily for 3 months


Baseline Measures
   Fluvastatin 
Overall Participants Analyzed 
[Units: Participants]
 41 
Age [1] 
[Units: Participants]
Count of Participants
 
<=18 years   0 
Between 18 and 65 years   41 
>=65 years   0 
[1] Ages between 18 and 65
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      31  75.6% 
Male      10  24.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Caucasian   28 
Region of Enrollment 
[Units: Participants]
 
United States   41 


  Outcome Measures

1.  Primary:   Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients   [ Time Frame: 3 months ]

2.  Primary:   Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients   [ Time Frame: 3 months ]

3.  Primary:   Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: erkand@hss.edu


Publications:

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