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J Cardiovasc Transl Res. 2014 Mar;7(2):226-31. doi: 10.1007/s12265-013-9513-9. Epub 2013 Oct 19.

Double-blind parallel placebo-controlled study to evaluate the effect of molsidomine on the endothelial dysfunction in patients with stable angina pectoris undergoing percutaneous coronary intervention: the MEDCOR Trial.

Author information

1
Cardiovascular Center Aalst, OLV Clinic, Moorselbaan n. 164, 9300, Aalst, Belgium, barba22@hotmail.com.

Abstract

The effects of molsidomine (a direct nitric oxide donor) on the endothelial dysfunction have never been evaluated using reactive hyperemia peripheral arterial tonometry (RH-PAT). The objective of the MEDCOR double-blind trial will be to demonstrate the superiority of molsidomine (Coruno® 16 mg, once daily) over placebo, on improving the endothelial function (Endoscore by RH-PAT) after 12 months of treatment in stable angina patients undergoing elective percutaneous coronary intervention (PCI). Study design will take care of the real-life situation, in which patients are being offered PCI and stent placement (drug-eluting or bare metal), but also gold standard medical therapy (beta-blockers, statins, angiotensin-converting enzyme inhibitors (ACEIs), and/or calcium antagonists). Demonstrating clinical and statistical superiority of the study drug over placebo will be a real challenge. Therefore, a sequential approach has been designed with a pilot phase aiming at recruiting 50 patients. Upon evaluation of the results by an independent data steering committee, a larger sample size phase will eventually be considered.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01363661.

PMID:
24142804
DOI:
10.1007/s12265-013-9513-9
[Indexed for MEDLINE]

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