Correlation of Endothelial Function and Early Coronary Artery Disease in Humans

NCT00271492 | Completed Phase 3 DMC

• 1 other identifier: 48-99
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• To find out what effects (good and bad) the medication Atrasentan has on the heart

  6 months

Study Arms (2)

I

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

placebo group to be compared to the actual medication

Drug: atrasentan

Interventions

atrasentan DRUG

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

Also known as: Xinlay

I

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Reriani M, Raichlin E, Prasad A, Mathew V, Pumper GM, Nelson RE, Lennon R, Rihal C, Lerman LO, Lerman A. Long-term administration of endothelin receptor antagonist improves coronary endothelial function in patients with early atherosclerosis. Circulation. 2010 Sep 7;122(10):958-66. doi: 10.1161/CIRCULATIONAHA.110.967406. Epub 2010 Aug 23.

  PMID: 20733096 DERIVED

MeSH Terms

Interventions

Atrasentan

Intervention Hierarchy (Ancestors)

Benzodioxoles; Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrrolidines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Amir Lerman, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2005
• First Posted: January 2, 2006
• Study Start: July 1, 2001
• Primary Completion: June 1, 2006
• Study Completion: January 1, 2008
• Last Updated: April 30, 2010

Record last verified: 2010-04

Locations

US (1)