Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment petn, isdn
Sponsor Julius-Maximilians University
Start date January 2007
End date November 2008
Trial size 50 participants
Trial identifier NCT01030367, 0001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
PETN
petn, isdn
Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day
(Experimental)
ISDN
petn, isdn
Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day
(No Intervention)
petn, isdn
Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day

Primary Outcomes

Measure
Endothelial function Number of endothelial progenitor cells Function of endothelial progenitor cells
time frame: Baseline and after 14d

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - Coronary artery disease, 2- or 3-vessel disease Exclusion Criteria: - Acute myocardial infarction, acute heart failure, cancer, acute infections

Additional Information

Official title Pilot Study of Organic Nitrates on Endothelial Progenitor Cells and Endothelial Function in Patients With Coronary Artery Disease
Principal investigator Thomas Thum, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by Julius-Maximilians University.