Institutional Review Board, Hospital for Special Surgery
March 13, 2008
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
The purpose of this study is to determine whether a drug named Fluvastatin (Lescol®) is beneficial and safe in reducing the risk of cardiovascular disease and blood clots in patients with antiphospholipid antibodies or Antiphospholipid Syndrome (APS).
If you decide to be in this study, the following routine and/or experimental procedures will be performed: You will be asked to come to the Rheumatology Clinic at the Hospital for Special Surgery for a total of 8 visits. These include 1 initial screening visit and 7 following subsequent appointments: baseline (first visit), and at months one, two, three, four, five and six.
Within a week of your screening visit, at your baseline visit, the study doctor will prescribe Fluvastatin 40 mg daily for 3 months.
During your visits the study investigators will interview you and review your medical records to obtain detailed information about your medical history. You will also have a brief physical examination by the study doctor. A sample of blood will be obtained (25 ml sample, equivalent to two tablespoons) at each study visit.
You can not take part in this study if you are:
o Younger than 18 year-old;
o Planning to get pregnant within the next 6 months
o Taking other cholesterol lowering agents
o Taking other immunosuppressive medications (such as methotrexate, azathioprine, cellcept, enbrel, remicade, or rituximab). Of note, you are allowed to take hydroxychloroquine (Plaquenil) during the study period.
o Treatment with biologic agents including anti-TNF medications and Rituximab
o Treatment with erythromycin, itraconazole, or clarithromycin
o Taking prednisone higher than 10mg daily
o Taking non-steroidal anti-inflammatory drug (such as Motin, Advil, etc) regularly
o Have a muscle or liver disease
o Have chronic renal disease requiring dialysis
o Have hepatitis C and/or HIV infection
o Have active infections requiring antibiotics
o Have the diagnosis of a systemic autoimmune disease (such as rheumatoid arthritis or systemic sclerosis) other than lupus
o Have diagnosis of another chronic condition requiring corticosteroid treatment more than 10mg daily
o History of an allergic reaction to cholesterol lowering agents