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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.

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.
AuthorsEmanuele Barbato, Arnold Herman, Edouard Benit, Luc Janssens, Jacques Lalmand, Etienne Hoffer, Patrick Chenu, Antoine Guédès, Luc Missault, Bruno Pirenne, François Cardinal, Steven Vercauteren, William Wijns
JournalJournal of cardiovascular translational research (J Cardiovasc Transl Res) Vol. 7 Issue 2 Pg. 226-31 (Mar 2014) ISSN: 1937-5395 [Electronic] United States
PMID24142804 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Nitric Oxide Donors
  • Molsidomine
Topics
  • Angina, Stable (diagnosis, physiopathology, therapy)
  • Belgium
  • Clinical Protocols
  • Coronary Vessels (drug effects, physiopathology)
  • Double-Blind Method
  • Drug Therapy, Combination
  • Endothelium, Vascular (drug effects, physiopathology)
  • Humans
  • Molsidomine (therapeutic use)
  • Nitric Oxide Donors (therapeutic use)
  • Percutaneous Coronary Intervention (adverse effects, instrumentation)
  • Pilot Projects
  • Research Design
  • Stents
  • Time Factors
  • Treatment Outcome

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