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.
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Authors | Emanuele 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 |
Journal | Journal of cardiovascular translational research
(J Cardiovasc Transl Res)
Vol. 7
Issue 2
Pg. 226-31
(Mar 2014)
ISSN: 1937-5395 [Electronic] United States |
PMID | 24142804
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Nitric Oxide Donors
- Molsidomine
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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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