Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417417
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2006-12-29
Brief Title:
Rilonacept to Improve Artery Function in Patients With Atherosclerosis
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Interleukin-1 Inhibition on C-Reactive Protein Levels Endothelial Progenitor Cell Mobilization and Endothelial Function in Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgL 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
Patients 18 years of age and older with atherosclerotic coronary artery disease with a CRP level between 2 and 10 mgL 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
Detailed Description:
Rilonacept Interleukin-1 Trap has been developed as an antagonist of the cytokine IL-1 in the treatment of rheumatoid arthritis and other inflammatory diseases IL-1 causes leukocyte accumulation by inducing adhesion receptors on vascular endothelium and stimulating chemokine production It also stimulates the synthesis of other cytokines including IL-6 which in turn stimulates synthesis of C-reactive protein CRP in the liver Based on numerous clinical studies CRP has emerged as a risk marker for the development and clinical expression of atherosclerotic cardiovascular disease leading to published recommendations for measurement of CRP in screening population subsets for cardiovascular risk Endothelial function as evidenced by stimulated nitric oxide release has also been recognized as a marker of cardiovascular disease risk Thus patients with coronary artery disease CAD or its risk factors have impaired nitric oxide release from the endothelium compared with healthy subjects Recent studies have shown that CRP levels were significantly higher in CAD patients compared with healthy subjects with an inverse correlation between forearm blood flow responses to acetylcholine as a measure of endothelial function and CRP Endothelial progenitor cells EPCs are primitive bone marrow-derived cells that have a capacity to home to sites of vascular injury and differentiate into vascular cell types and are reduced in number and differentiation capacity in CAD patients relative to healthy subjects Studies suggest that CRP inhibits viability and endothelial differentiation capacity of EPCs and may account for reduced numbers of EPCs and endothelial dysfunction in CAD patients The objective of the present study is to demonstrate the potential of an investigational biological agent rilonacept as adjunctive treatment for CAD by examining effects of this agent on CRP levels endothelial progenitor cell mobilization and endothelial function in a randomized double-blind placebo-controlled phase III clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-H-0055 | OTHER | NIH Clinical Center protocol 07-H-0055 | None |