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
| Autor: | Jacques Lalmand, Luc Missault, François Cardinal, Patrick Chenu, Antoine Guedes, Luc Janssens, Arnold G. Herman, Etienne Hoffer, Emanuele Barbato, Edouard Benit, Steven Vercauteren, William Wijns, Bruno Pirenne |
|---|---|
| Přispěvatelé: | Barbato, Emanuele, Herman, A, Benit, E, Janssens, L, Lalmand, J, Hoffer, E, Chenu, P, Gu?d?s, A, Missault, L, Pirenne, B, Cardinal, F, Vercauteren, S, Wijns, W. |
| Rok vydání: | 2014 |
| Předmět: |
medicine.medical_specialty
Time Factors medicine.medical_treatment Placebo-controlled study Pharmaceutical Science Pilot Projects Placebo law.invention Angina Percutaneous Coronary Intervention Randomized controlled trial Belgium Clinical Protocols Double-Blind Method law Internal medicine Genetics medicine Humans Nitric Oxide Donors cardiovascular diseases Angina Stable Endothelial dysfunction Reactive hyperemia Genetics (clinical) business.industry Percutaneous coronary intervention medicine.disease Coronary Vessels Treatment Outcome Research Design Molsidomine Conventional PCI Cardiology Molecular Medicine Drug Therapy Combination Stents Endothelium Vascular Cardiology and Cardiovascular Medicine business |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|