Correlation of Endothelial Function and Early Coronary Artery Disease in Humans

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00271492
First received: December 29, 2005
Last updated: April 28, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Endothelial Dysfunction
Drug: Atrasentan
Drug: atrasentan
Phase 3

Study Type: Interventional
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

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To find out what effects (good and bad) the medication Atrasentan has on the heart [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: July 2001
Study Completion Date: January 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271492

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Amir Lerman, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amir Lerman, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00271492     History of Changes
Other Study ID Numbers: 48-99
Study First Received: December 29, 2005
Last Updated: April 28, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014