Correlation of Endothelial Function and Early Coronary Artery Disease in Humans
Qualifying patients who are scheduled for angiogram with endothelial function testing are approached to participate in this protocol (consent form reviewed with patient). Those who are willing to participate will have additional measurements taken during their angiogram as part of this protocol. Patients who are diagnosed with Endothelial Dysfunction as a result of a clinically indicated angiogram will be eligible to participate in a 6 month medication trial (Atrasentan vs. placebo - randomized, blinded trial). Patients are monitored closely during the 6 month trial via phone calls and blood testing for assessment. At the end of the 6 months they return to Mayo for a repeat angiogram to assess endothelial function for any changes or improvements.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Endothelin in the Coronary Circulation in Early Atherosclerosis in Humans|
- To find out what effects (good and bad) the medication Atrasentan has on the heart [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2001|
|Study Completion Date:||January 2008|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Active Comparator: I
Qualifying patients took Atrasentan, 1 pill per day for 6 months, to determine if it had a favorable affect on patients who took it over those who were randomized to placebo.
1 10mg capsule to be taken daily for 6 month study period.
Other Name: XinlayDrug: Atrasentan
1 10mg capsule per day for the 6 month study period.
Other Name: Xinlay
Placebo Comparator: 2
placebo group to be compared to the actual medication
One 10 mg capsule per day for 6 month study period
Other Name: Xinlay
Aim I: To determine the activity of the endogenous endothelin system in the coronary circulation in humans with coronary endothelial dysfunction and atherosclerosis risk factors. Aim II: To assess the potential of chronic endothelin receptor antagonists to improve preexisting coronary endothelial dysfunction and myocardial perfusion in humans and Aim III: To assess the effect of chronic endothelin receptor antagonism on the endogenous nitric oxide system in association with oxidative stress in humans with early coronary disease risk factors.
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Amir Lerman, M.D.||Mayo Clinic|