• Citer

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

par Barbato, Emanuele;Herman, Arnold;Benit, Edouard;Janssens, Luc ;Lalmand, Jacques;Hoffer, Etienne;Chenu, Patrick;Guédès, Antoine;Missault, Luc;Pirenne, Bruno;Cardinal, François;Vercauteren, Steven;Wijns, William
Référence Journal of Cardiovascular Translational Research, 7, 2, page (226-231)
Publication Publié, 2014

Article révisé par les pairs

• Détails
• Contenu

Résumé :

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.