Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial
Introduction It is the common clinical practice to prescribe indefinite aspirin for patients with non-valvular atrial fibrillation (NVAF) post left atrial appendage occlusion (LAAO). However, aspirin as a primary prevention strategy for cardiovascular diseases has recently been challenged due to inc...
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doaj-acc619dbfbf247bfb9266f0fb842fb272021-07-02T13:05:10ZengBMJ Publishing GroupBMJ Open2044-60552021-03-0111310.1136/bmjopen-2020-044695Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trialXiaochen Wang0Yansong Li1Bin Yang2Jian Sun3Mu Chen4Qunshan Wang5Peng-Pai Zhang6Bin-Feng Mo7Tai-Zhong Chen8Xiaoli Tang9Yi-Gang Li10Jian-An Wang11An-Li Tang; Hao HuSi-Ming TaoQi Lu12Zongjun Liu13Zhaohui QiuChun Gui1 Department of Hepatobiliary Surgery, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China Multiple Organ Support Technology, US Army Institute of Surgical Research, Fort Sam Houston, Texas, USA2 Department of Anaesthesiology, Chongqing University Cancer Hospital, Chongqing, China Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Cardiology, Key Lab of Cardiovascular Disease, Second Affiliated Hospital of Zhejiang University School of Medicine3Hematology Research, Cambridge, Massachusetts, USA1 Department of Cardiology, Putuo Hospital affiliated to Shanghai Traditional Chinese Medicine University, Shanghai, ChinaIntroduction It is the common clinical practice to prescribe indefinite aspirin for patients with non-valvular atrial fibrillation (NVAF) post left atrial appendage occlusion (LAAO). However, aspirin as a primary prevention strategy for cardiovascular diseases has recently been challenged due to increased risk of bleeding. Therefore, aspirin discontinuation after LAAO in atrial fibrillation (ASPIRIN LAAO) trial is designed to assess the uncertainty about the risks and benefits of discontinuing aspirin therapy at 6 months postimplantation with a Watchman LAAO device in NVAF patients.Methods and analysis The ASPIRIN LAAO study is a prospective, multicentre, randomised, double-blinded, placebo-controlled non-inferiority trial. Patients implanted with a Watchman device within 6 months prior to enrollment and without pre-existing conditions requiring long-term aspirin therapy according to current guidelines are eligible for participating the trial. Subjects will be randomised in a 1:1 allocation ratio to either the Aspirin group (aspirin 100 mg/day) or the control group (placebo) at 6 months postimplantation. A total of 1120 subjects will be enrolled from 12 investigational sites in China. The primary composite endpoint is stroke, systemic embolism, cardiovascular/unexplained death, major bleeding, acute coronary syndrome and coronary or periphery artery disease requiring revascularisation at 24 months. Follow-up visits are scheduled at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment.Ethics and dissemination Ethics approval was obtained from the Ethics Committee of Xinhua Hospital, Shanghai, China (reference number XHEC-C-2018-065-5). The protocol is also submitted and approved by the institutional Ethics Committee at each participating centre. Results are expected in 2024 and will be disseminated through peer-reviewed journals and presentations at national and international conferences.Trial registration number NCT03821883.https://bmjopen.bmj.com/content/11/3/e044695.full |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Xiaochen Wang Yansong Li Bin Yang Jian Sun Mu Chen Qunshan Wang Peng-Pai Zhang Bin-Feng Mo Tai-Zhong Chen Xiaoli Tang Yi-Gang Li Jian-An Wang An-Li Tang; Hao Hu Si-Ming Tao Qi Lu Zongjun Liu Zhaohui Qiu Chun Gui |
spellingShingle |
Xiaochen Wang Yansong Li Bin Yang Jian Sun Mu Chen Qunshan Wang Peng-Pai Zhang Bin-Feng Mo Tai-Zhong Chen Xiaoli Tang Yi-Gang Li Jian-An Wang An-Li Tang; Hao Hu Si-Ming Tao Qi Lu Zongjun Liu Zhaohui Qiu Chun Gui Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial BMJ Open |
author_facet |
Xiaochen Wang Yansong Li Bin Yang Jian Sun Mu Chen Qunshan Wang Peng-Pai Zhang Bin-Feng Mo Tai-Zhong Chen Xiaoli Tang Yi-Gang Li Jian-An Wang An-Li Tang; Hao Hu Si-Ming Tao Qi Lu Zongjun Liu Zhaohui Qiu Chun Gui |
author_sort |
Xiaochen Wang |
title |
Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial |
title_short |
Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial |
title_full |
Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial |
title_fullStr |
Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial |
title_full_unstemmed |
Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial |
title_sort |
double-blind, placebo-controlled randomised clinical trial to evaluate the effect of aspirin discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the aspirin laao trial |
publisher |
BMJ Publishing Group |
series |
BMJ Open |
issn |
2044-6055 |
publishDate |
2021-03-01 |
description |
Introduction It is the common clinical practice to prescribe indefinite aspirin for patients with non-valvular atrial fibrillation (NVAF) post left atrial appendage occlusion (LAAO). However, aspirin as a primary prevention strategy for cardiovascular diseases has recently been challenged due to increased risk of bleeding. Therefore, aspirin discontinuation after LAAO in atrial fibrillation (ASPIRIN LAAO) trial is designed to assess the uncertainty about the risks and benefits of discontinuing aspirin therapy at 6 months postimplantation with a Watchman LAAO device in NVAF patients.Methods and analysis The ASPIRIN LAAO study is a prospective, multicentre, randomised, double-blinded, placebo-controlled non-inferiority trial. Patients implanted with a Watchman device within 6 months prior to enrollment and without pre-existing conditions requiring long-term aspirin therapy according to current guidelines are eligible for participating the trial. Subjects will be randomised in a 1:1 allocation ratio to either the Aspirin group (aspirin 100 mg/day) or the control group (placebo) at 6 months postimplantation. A total of 1120 subjects will be enrolled from 12 investigational sites in China. The primary composite endpoint is stroke, systemic embolism, cardiovascular/unexplained death, major bleeding, acute coronary syndrome and coronary or periphery artery disease requiring revascularisation at 24 months. Follow-up visits are scheduled at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment.Ethics and dissemination Ethics approval was obtained from the Ethics Committee of Xinhua Hospital, Shanghai, China (reference number XHEC-C-2018-065-5). The protocol is also submitted and approved by the institutional Ethics Committee at each participating centre. Results are expected in 2024 and will be disseminated through peer-reviewed journals and presentations at national and international conferences.Trial registration number NCT03821883. |
url |
https://bmjopen.bmj.com/content/11/3/e044695.full |
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