PMID- 32663660 OWN - NLM STAT- MEDLINE DCOM- 20201008 LR - 20201008 IS - 1097-6744 (Electronic) IS - 0002-8703 (Linking) VI - 227 DP - 2020 Sep TI - 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. PG - 19-30 LID - S0002-8703(20)30185-X [pii] LID - 10.1016/j.ahj.2020.06.005 [doi] AB - BACKGROUND: 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 (alpha = 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. CI - Copyright (c) 2020 Elsevier Inc. All rights reserved. FAU - Yan, Yan AU - Yan Y AD - Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: eva3321@sina.com. FAU - Wang, Xiao AU - Wang X AD - Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: spaceeye123@126.com. FAU - Guo, Jincheng AU - Guo J AD - Beijing Luhe Hospital, Capital Medical University, Beijing, China. Electronic address: guojcmd@126.com. FAU - Li, Yongjun AU - Li Y AD - The Second Hospital of Hebei Medical University, Shijiazhuang, China. Electronic address: lyjbs2009@yeah.net. FAU - Ai, Hui AU - Ai H AD - Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: aihui0814@126.com. FAU - Gong, Wei AU - Gong W AD - Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: tjmusky@126.com. FAU - Que, Bin AU - Que B AD - Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: quebin@sohu.com. FAU - Zhen, Lei AU - Zhen L AD - Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: 13439546840@yeah.net. FAU - Lu, Jiapeng AU - Lu J AD - National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: jiapeng.lu@fwoxford.org. FAU - Ma, Changsheng AU - Ma C AD - Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. Electronic address: chshma@vip.sina.com. FAU - Montalescot, Gilles AU - Montalescot G AD - Sorbonne University, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Hopital Pitie-Salpetriere (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr. FAU - Nie, Shaoping AU - Nie S AD - Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: spnie@ccmu.edu.cn. LA - eng PT - Clinical Trial Protocol PT - Comparative Study PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20200620 PL - United States TA - Am Heart J JT - American heart journal JID - 0370465 RN - 0 (Anticoagulants) RN - 0 (Enoxaparin) RN - 0 (Hirudins) RN - 0 (Peptide Fragments) RN - 0 (Recombinant Proteins) RN - 9005-49-6 (Heparin) RN - TN9BEX005G (bivalirudin) SB - IM MH - Anticoagulants/*administration & dosage MH - Double-Blind Method MH - Enoxaparin/*administration & dosage MH - Heparin/*administration & dosage MH - Hirudins/*administration & dosage MH - Humans MH - Multicenter Studies as Topic/methods MH - Peptide Fragments/*administration & dosage MH - *Percutaneous Coronary Intervention MH - Postoperative Period MH - Prospective Studies MH - Randomized Controlled Trials as Topic/*methods MH - Recombinant Proteins/administration & dosage MH - ST Elevation Myocardial Infarction/*drug therapy/*surgery MH - Time Factors EDAT- 2020/07/15 06:00 MHDA- 2020/10/09 06:00 CRDT- 2020/07/15 06:00 PHST- 2020/02/10 00:00 [received] PHST- 2020/06/07 00:00 [accepted] PHST- 2020/07/15 06:00 [pubmed] PHST- 2020/10/09 06:00 [medline] PHST- 2020/07/15 06:00 [entrez] AID - S0002-8703(20)30185-X [pii] AID - 10.1016/j.ahj.2020.06.005 [doi] PST - ppublish SO - Am Heart J. 2020 Sep;227:19-30. doi: 10.1016/j.ahj.2020.06.005. Epub 2020 Jun 20.