Correlation of Endothelial Function and Early Coronary Artery Disease in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00271492
Recruitment Status : Completed
First Posted : January 2, 2006
Last Update Posted : April 30, 2010
National Institutes of Health (NIH)
Information provided by:
Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Drug: Atrasentan Drug: atrasentan Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endothelin in the Coronary Circulation in Early Atherosclerosis in Humans
Study Start Date : July 2001
Actual Primary Completion Date : June 2006
Actual Study Completion Date : January 2008

Arm Intervention/treatment
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.
Drug: Atrasentan
1 10mg capsule to be taken daily for 6 month study period.
Other Name: Xinlay

Drug: 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
Drug: atrasentan
One 10 mg capsule per day for 6 month study period
Other Name: Xinlay

Primary Outcome Measures :
  1. To find out what effects (good and bad) the medication Atrasentan has on the heart [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years and < 85 years
  • Male or female

Exclusion criteria:

  • Left dominant circulation
  • Heart failure with EF <40%
  • Unstable angina
  • MI or angioplasty of the LAD or circumflex with 6 months prior to entry into the study
  • Use of radiographic contrast agent within 12 hours of entry into the study
  • Use of investigational agents within one month of entry into the study
  • Patients who require treatment with positive inotropic agents other than digoxin during the study
  • Patients with cerebrovascular accident within 6 months prior to entry into the study
  • Significant endocrine, hepatic, renal disorders; local or systemic infectious disease within 4 weeks prior to entry into study
  • Pregnancy or lactation
  • Mental instability
  • Federal Medical Center patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00271492

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
Principal Investigator: Amir Lerman, M.D. Mayo Clinic

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Amir Lerman, M.D., Mayo Clinic Identifier: NCT00271492     History of Changes
Other Study ID Numbers: 48-99
First Posted: January 2, 2006    Key Record Dates
Last Update Posted: April 30, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action