title: 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.
authors.affiliation: Cardiovascular Center Aalst, OLV Clinic, Moorselbaan n. 164, 9300, Aalst, Belgium, barba22@hotmail.com.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Barbato
authors.forename: Arnold
authors.initials: A
authors.lastname: Herman
authors.forename: Edouard
authors.initials: E
authors.lastname: Benit
authors.forename: Luc
authors.initials: L
authors.lastname: Janssens
authors.forename: Jacques
authors.initials: J
authors.lastname: Lalmand
authors.forename: Etienne
authors.initials: E
authors.lastname: Hoffer
authors.forename: Patrick
authors.initials: P
authors.lastname: Chenu
authors.forename: Antoine
authors.initials: A
authors.lastname: Guédès
authors.forename: Luc
authors.initials: L
authors.lastname: Missault
authors.forename: Bruno
authors.initials: B
authors.lastname: Pirenne
authors.forename: François
authors.initials: F
authors.lastname: Cardinal
authors.forename: Steven
authors.initials: S
authors.lastname: Vercauteren
authors.forename: William
authors.initials: W
authors.lastname: Wijns
mesh_terms: D060050:Angina, Stable / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D001530:Belgium; D002985:Clinical Protocols; D003331:Coronary Vessels / Q000187:drug effects* / Q000503:physiopathology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004730:Endothelium, Vascular / Q000187:drug effects* / Q000503:physiopathology; D006801:Humans; D008981:Molsidomine / Q000627:therapeutic use*; D020030:Nitric Oxide Donors / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation; D010865:Pilot Projects; D012107:Research Design; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D020030:Nitric Oxide Donors; D008981:Molsidomine