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Pilot Study of Organic Nitrates on Endothelial Function in CAD Patients

NCT ID: NCT01030367

Last Updated: 2009-12-11

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-01-31

Brief Summary

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Organic nitrates increase levels of circulating endothelial progenitor cells (Thum et al., Arterioscler Thromb Vasc Biol. 2007 Apr;27(4):748-54). Here, we want to test the effects of two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor cells and endothelial function.

Detailed Description

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In this pilot study we test the effects of two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor cells and endothelial function. These parameters will be measured before and after 14d of treatment.

Conditions

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Coronary Artery Disease

Keywords

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Coronary artery disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

PETN

Group Type EXPERIMENTAL

PETN, ISDN

Intervention Type DRUG

Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day

2

ISDN

Group Type EXPERIMENTAL

PETN, ISDN

Intervention Type DRUG

Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day

3

Group Type NO_INTERVENTION

PETN, ISDN

Intervention Type DRUG

Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day

Interventions

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PETN, ISDN

Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Coronary artery disease, 2- or 3-vessel disease

Exclusion Criteria

* Acute myocardial infarction, acute heart failure, cancer, acute infections
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Julius-Maximilians University

OTHER

Sponsor Role lead

Responsible Party

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Julius-Maximilians University

Principal Investigators

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Thomas Thum, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Würzburg

Locations

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Julius-Maximilians University

Würzburg, Bavaria, Germany

Site Status

Countries

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Germany

References

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Thum T, Fraccarollo D, Thum S, Schultheiss M, Daiber A, Wenzel P, Munzel T, Ertl G, Bauersachs J. Differential effects of organic nitrates on endothelial progenitor cells are determined by oxidative stress. Arterioscler Thromb Vasc Biol. 2007 Apr;27(4):748-54. doi: 10.1161/01.ATV.0000258787.18982.73. Epub 2007 Jan 25.

Reference Type BACKGROUND
PMID: 17255540 (View on PubMed)

Other Identifiers

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0001

Identifier Type: -

Identifier Source: org_study_id