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Correlation of Endothelial Function and Early Coronary Artery Disease in Humans

NCT ID: NCT00271492

Last Updated: 2010-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Atrasentan

Intervention Type DRUG

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

Atrasentan

Intervention Type DRUG

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

2

placebo group to be compared to the actual medication

Group Type PLACEBO_COMPARATOR

atrasentan

Intervention Type DRUG

One 10 mg capsule per day for 6 month study period

Interventions

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Atrasentan

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

Intervention Type DRUG

Atrasentan

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

Intervention Type DRUG

atrasentan

One 10 mg capsule per day for 6 month study period

Intervention Type DRUG

Other Intervention Names

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Xinlay Xinlay Xinlay

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Amir Lerman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20733096 (View on PubMed)

Other Identifiers

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48-99

Identifier Type: -

Identifier Source: org_study_id