Rilonacept to Improve Artery Function in Patients With Atherosclerosis
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
Summary
This study will determine whether an experimental drug called Rilonacept can improve artery
function in patients with atherosclerosis, a disease in which fatty deposits in arteries
cause the vessels to stiffen, impeding blood flow. Atherosclerosis is believed to be caused
in part by inflammation. Rilonacept blocks production of a protein called CRP, which, in high
levels in the blood is associated with increased inflammation. Patients with coronary artery
disease who have elevated blood levels of CRP are at increased risk of heart attack, heart
failure and sudden death compared with people who have lower levels of the protein.
Patients 18 years of age and older with atherosclerotic coronary artery disease with a CRP
level between 2 and 10 mg/L may be eligible for this study.
Patients are randomly assigned to receive four doses of either Rilonacept or placebo, given
at 2-week intervals as injections under the skin. In addition to treatment, patients undergo
the following procedures during eight visits to the NIH Clinical Center:
- Visit 1 (screening visit): Medical history, measurement of vital signs (temperature,
blood pressure, heart rate and breathing rate), electrocardiogram (EKG) and blood tests.
- Visit 2: Blood tests, chest X-ray, treadmill exercise testing, tuberculin skin test,
brachial artery flow-mediated dilation. Brachial artery flow-mediated dilation is used
to measure how well the brachial artery (artery inside the elbow) dilates. An ultrasound
device placed just above the elbow measures the size of the brachial artery and the flow
of blood through it before and after a pressure cuff is inflated around the forearm.
- Visit 3: Injection of study drug.
- Visits 4, 5, and 6: Review of any changes in health or medical treatment, measurement of
vital signs, blood tests, EKG, injection of study drug.
- Visit 7: Review of any changes in health or medical treatment, measurement of vital
signs, blood tests, EKG, treadmill exercise testing, brachial artery flow-mediated
dilation.
- Visit 8: Review of any changes in health or medical treatment, measurement of vital
signs, blood tests, EKG, treadmill exercise testing, brachial artery flow-mediated
dilation.