51. Rationale and design of the RIGHT trial: A multicenter, randomized, double-blind, placebo-controlled trial of anticoagulation prolongation versus no anticoagulation after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction
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Jiapeng Lu, Shaoping Nie, Jincheng Guo, Lei Zhen, Yan Yan, Gilles Montalescot, Wei Gong, Hui Ai, Xiao Wang, Yongjun Li, Changsheng Ma, Bin Que, Capital University of Medical Sciences [Beijing] (CUMS), Hebei University, Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut de cardiologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and CCSD, Accord Elsevier
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Relative risk reduction ,medicine.medical_specialty ,Time Factors ,medicine.drug_class ,medicine.medical_treatment ,[SDV]Life Sciences [q-bio] ,Placebo-controlled study ,030204 cardiovascular system & hematology ,Revascularization ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Double-Blind Method ,Internal medicine ,medicine ,Bivalirudin ,Humans ,Multicenter Studies as Topic ,030212 general & internal medicine ,Myocardial infarction ,Postoperative Period ,Prospective Studies ,Enoxaparin ,Stroke ,Randomized Controlled Trials as Topic ,business.industry ,Heparin ,Anticoagulant ,Percutaneous coronary intervention ,Anticoagulants ,Hirudins ,medicine.disease ,Peptide Fragments ,Recombinant Proteins ,3. Good health ,[SDV] Life Sciences [q-bio] ,Cardiology ,ST Elevation Myocardial Infarction ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
International audience; Full text linksfull-text provider logoActionsFavoritesSharePage navigation Title & authors Abstract Similar articles Publication types MeSH terms Substances Related information LinkOut - more resourcesComparative StudyAm Heart J. 2020 Sep;227:19-30.doi: 10.1016/j.ahj.2020.06.005. Epub 2020 Jun 20.Rationale and design of the RIGHT trial: A multicenter, randomized, double-blind, placebo-controlled trial of anticoagulation prolongation versus no anticoagulation after primary percutaneous coronary intervention for ST-segment elevation myocardial infarctionYan Yan 1 , Xiao Wang 2 , Jincheng Guo 3 , Yongjun Li 4 , Hui Ai 5 , Wei Gong 6 , Bin Que 7 , Lei Zhen 8 , Jiapeng Lu 9 , Changsheng Ma 10 , Gilles Montalescot 11 , Shaoping Nie 12Affiliations PMID: 32663660 DOI: 10.1016/j.ahj.2020.06.005 AbstractBackground: Current guidelines recommend anticoagulation therapy during primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI). However, whether anticoagulation should be continued after pPCI has not been well investigated.Methods/design: The RIGHT trial is a prospective, multicenter, randomized, double-blind, placebo-controlled trial in STEMI patients treated with pPCI evaluating the prolongation of anticoagulation after the procedure. Patients are randomized in a 1:1 fashion to receive either prolonged anticoagulant or matching placebo (no anticoagulation) for at least 48 hours after the procedure. When randomized to anticoagulation prolongation, the patient is assigned to intravenous unfractionated heparin (UFH) or subcutaneous enoxaparin or intravenous bivalirudin (same drug and same regimen at each center). The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days. The primary safety endpoint is major bleeding (BARC 3-5) at 30 days. Based on a superiority design and assuming a 35% relative risk reduction (from 7% to 4.5%), 2856 patients will be enrolled, accounting for a 5% drop-out rate (α = 0.05 and power = 80%).Conclusion: The RIGHT trial tests the hypothesis that post-procedural anticoagulation is superior to no anticoagulation in reducing ischemic events in STEMI patients undergoing pPCI.
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- 2020