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

Barbato, E.;Herman, A.;Benit, E.;Janssens, L.;Wijns, W.;et.al.
(2013) Journal of Cardiovascular Translational Research — Vol. 7, n° 2, p. 226-231 (2014)

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Authors
  • Barbato, E.
    Author
  • Herman, A.
    Author
  • Benit, E.
    Author
  • Janssens, L.
    Author
  • Chenu, PatrickUCLouvain
    Author
  • Guedes, AntoineUCLouvain
    Author
  • Wijns, W.
    Author
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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. © 2013 Springer Science+Business Media New York.
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Barbato, E., Herman, A., Benit, E., Janssens, L., Lalmand, J., Hoffer, E., Chenu, P., Guedes, A., Missault, L., Pirenne, B., Cardinal, F., Vercauteren, S., & Wijns, W. (2013). 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. Journal of Cardiovascular Translational Research, 7(2), 226-231. https://doi.org/10.1007/s12265-013-9513-9 (Original work published 2014)