Wenbin Lu1, Lijuan Chen1, Yu Wang1, Yuyu Yao1, Cong Fu1, Pengfei Zuo1, Genshan Ma2. 1. Department of Cardiology, ZhongDa Hospital affiliated to Southeast University, China. 2. Department of Cardiology, ZhongDa Hospital affiliated to Southeast University, China. Electronic address: magenshanseu@163.com.
Abstract
BACKGROUND: Long-term oral anticoagulant treatment is obligatory in patients with atrial fibrillation (AF, score of CHA₂DS₂VASc≥2). When these patients undergo percutaneous coronary intervention with a drug-eluting stent (PCI-eS), there is also an indication for aspirin and clopidogrel treatment, according to the ESC Guidelines. However, triple therapy has been known to increase the risk of bleeding complications. Unfortunately, there is little prospective data available to resolve this issue. Therefore, it is imperative that an optimal therapy for AF patients with indications of both anticoagulation and antiplatelet intervention to prevent thrombotic complications without increasing the risk of bleeding is found. OBJECTIVES: This prospective, randomized, multicenter study is going to assess the hypothesis that in persistent or permanent AF patients (score of CHA₂DS₂VASc≥2) after PCI-eS, the combination therapy of oral anticoagulation (warfarin) and ticagrelor (90 mg/bid) could reduce the risk of bleeding events. DESIGN: A multicenter, active-controlled, open-label, randomized trial is to be performed to evaluate dual antithrombotic therapy (ticagrelor+warfarin) in persistent or permanent AF patients (score of CHA₂DS₂VASc≥2) after PCI-eS versus the combination of triple antithrombosis (clopidogrel+aspirin+warfarin). The primary endpoint is the overall bleeding up to 6 months, according to TIMI criteria and classifications. The secondary endpoints are the major bleeding events up to 6 months, according to TIMI criteria. The sample size is estimated at 296. CONCLUSION: This study is intended to provide information about the safety characteristics of warfarin and ticagrelor in persistent or permanent AF patients after PCI-eS. No prospective randomized study has been conducted on the issue of antithrombotic therapy using warfarin and ticagrelor in these patients. Therefore, the MANJUSRI trial will help to explore and determine a new potential therapeutic regimen for AF patients after PCI-eS. TRIAL REGISTRATION: Clinical Trials.gov # NCT02206815, registered July 30, 2014.
RCT Entities:
BACKGROUND: Long-term oral anticoagulant treatment is obligatory in patients with atrial fibrillation (AF, score of CHA₂DS₂VASc≥2). When these patients undergo percutaneous coronary intervention with a drug-eluting stent (PCI-eS), there is also an indication for aspirin and clopidogrel treatment, according to the ESC Guidelines. However, triple therapy has been known to increase the risk of bleeding complications. Unfortunately, there is little prospective data available to resolve this issue. Therefore, it is imperative that an optimal therapy for AFpatients with indications of both anticoagulation and antiplatelet intervention to prevent thrombotic complications without increasing the risk of bleeding is found. OBJECTIVES: This prospective, randomized, multicenter study is going to assess the hypothesis that in persistent or permanent AFpatients (score of CHA₂DS₂VASc≥2) after PCI-eS, the combination therapy of oral anticoagulation (warfarin) and ticagrelor (90 mg/bid) could reduce the risk of bleeding events. DESIGN: A multicenter, active-controlled, open-label, randomized trial is to be performed to evaluate dual antithrombotic therapy (ticagrelor+warfarin) in persistent or permanent AFpatients (score of CHA₂DS₂VASc≥2) after PCI-eS versus the combination of triple antithrombosis (clopidogrel+aspirin+warfarin). The primary endpoint is the overall bleeding up to 6 months, according to TIMI criteria and classifications. The secondary endpoints are the major bleeding events up to 6 months, according to TIMI criteria. The sample size is estimated at 296. CONCLUSION: This study is intended to provide information about the safety characteristics of warfarin and ticagrelor in persistent or permanent AFpatients after PCI-eS. No prospective randomized study has been conducted on the issue of antithrombotic therapy using warfarin and ticagrelor in these patients. Therefore, the MANJUSRI trial will help to explore and determine a new potential therapeutic regimen for AFpatients after PCI-eS. TRIAL REGISTRATION: Clinical Trials.gov # NCT02206815, registered July 30, 2014.
Authors: Abdelmoniem Moustafa; Mohammad Saud Khan; Abdalla Marei; Mohd Amer Alsamman; Muhammad Baig; Marwan Saad Journal: Avicenna J Med Date: 2020-10-13
Authors: Lisa Riesinger; Claudia Strobl; David M Leistner; Tommaso Gori; Ibrahim Akin; Michael Mehr; Antonia Kellnar; Amir A Mahabadi; Harilaos Bogossian; Michael Block; Frank Edelmann; Nikolaus Sarafoff; Dirk Sibbing; Hüseyin Ince; Tienush Rassaf; Ulrich Mansmann; Julinda Mehilli; Stefan Kääb; Jörg Hausleiter; Steffen Massberg; Reza Wakili Journal: Int J Cardiol Heart Vasc Date: 2021-07-01