Correlation of Endothelial Function and Early Coronary Artery Disease in Humans

NCT00271492 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-04-30

No results posted yet for this study

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.

Conditions

  • Endothelial Dysfunction

Interventions

DRUG

Atrasentan

1 10mg capsule to be taken daily for 6 month study period.

DRUG

Atrasentan

1 10mg capsule per day for the 6 month study period.

DRUG

atrasentan

One 10 mg capsule per day for 6 month study period

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Amir Lerman, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2006-06-30
Completion
2008-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00271492 on ClinicalTrials.gov