Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Hospital for Special Surgery, New York
Collaborator:
University of Texas
Information provided by (Responsible Party):
Doruk Erkan, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00674297
First received: May 5, 2008
Last updated: February 3, 2013
Last verified: February 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Antiphospholipid Syndrome |
Drug: Fluvastatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients |
Resource links provided by NLM:
Further study details as provided by Hospital for Special Surgery, New York:
Primary Outcome Measures:
- Pro-inflammatory and prothrombotic markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety of fluvastatin in antiphospholipid antibody-positive patients [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2008 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Fluvastatin |
Drug: Fluvastatin
Fluvastatin 40 mg daily for 3 months
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00674297
Locations
| United States, New York | |
| Hospital for Special Surgery | |
| New York, New York, United States, 10021 | |
| United States, Texas | |
| Division of Rheumatology, University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555 | |
Sponsors and Collaborators
Hospital for Special Surgery, New York
University of Texas
Investigators
| Principal Investigator: | Doruk Erkan, MD | Hospital for Special Surgery, New York |
| Principal Investigator: | Silvia Pierangeli, PhD | University of Texas |
More Information
No publications provided
| Responsible Party: | Doruk Erkan, Principal Investigator, Hospital for Special Surgery, New York |
| ClinicalTrials.gov Identifier: | NCT00674297 History of Changes |
| Other Study ID Numbers: | IRB 28005 |
| Study First Received: | May 5, 2008 |
| Last Updated: | February 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Hospital for Special Surgery, New York:
|
Persistently Antiphospholipid Antibody Positive Patients |
Additional relevant MeSH terms:
|
Antiphospholipid Syndrome Autoimmune Diseases Immune System Diseases Fluvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013