Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study

Introduction Current international guidelines recommend non-vitamin K oral anticoagulants (NOACs) for stroke prevention among patients with non-valvular atrial fibrillation (AF) at significant ischaemic stroke risk given the superior safety and comparable efficacy of NOACs over warfarin. Nonetheless...

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Veröffentlicht in:BMJ open 2020-09, Vol.10 (9), p.e038194-e038194, Article 038194
Hauptverfasser: Zhou, Mi, Chan, Esther W., Hai, Jo Jo, Wong, Chun Ka, Lau, Yuk Ming, Huang, Duo, Lam, Cheung Chi, Tam, Chor Cheung Frankie, Wong, Yiu Tung Anthony, Yung, See Yue Arthur, Chan, Ki Wan Kelvin, Feng, Yingqing, Tan, Ning, Chen, Ji-yan, Yung, Chi Yui, Lee, Kwok Lun, Choi, Chun Wai, Lam, Ho, Ng, Andrew, Fan, Katherine, Jim, Man Hong, Yiu, Kai Hang, Yan, Bryan P., Siu, Chung Wah
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container_issue 9
container_start_page e038194
container_title BMJ open
container_volume 10
creator Zhou, Mi
Chan, Esther W.
Hai, Jo Jo
Wong, Chun Ka
Lau, Yuk Ming
Huang, Duo
Lam, Cheung Chi
Tam, Chor Cheung Frankie
Wong, Yiu Tung Anthony
Yung, See Yue Arthur
Chan, Ki Wan Kelvin
Feng, Yingqing
Tan, Ning
Chen, Ji-yan
Yung, Chi Yui
Lee, Kwok Lun
Choi, Chun Wai
Lam, Ho
Ng, Andrew
Fan, Katherine
Jim, Man Hong
Yiu, Kai Hang
Yan, Bryan P.
Siu, Chung Wah
description Introduction Current international guidelines recommend non-vitamin K oral anticoagulants (NOACs) for stroke prevention among patients with non-valvular atrial fibrillation (AF) at significant ischaemic stroke risk given the superior safety and comparable efficacy of NOACs over warfarin. Nonetheless, the safety and effectiveness of NOACs have not been evaluated in patients with AF with underlying moderate or severe mitral stenosis (MS), hence the recommended stroke prevention strategy remains warfarin therapy. Method and analysis MS remains disproportionately prevalent in Asian countries compared with the developed countries. This prospective, randomised, open-label trial with blinded endpoint adjudication aims to evaluate the safety and efficacy of dabigatran for stroke prevention in AF patients with moderate or severe MS. Patients with AF aged >= 18 years with moderate or severe MS not planned for valvular intervention in the coming 12 months will be randomised in a 1:1 ratio to receive dabigatran 110 mg or 150 mg two times per day or warfarin with international normalised ratio 2-3 in an open-label design. Patients with estimated creatinine clearance
doi_str_mv 10.1136/bmjopen-2020-038194
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Nonetheless, the safety and effectiveness of NOACs have not been evaluated in patients with AF with underlying moderate or severe mitral stenosis (MS), hence the recommended stroke prevention strategy remains warfarin therapy. Method and analysis MS remains disproportionately prevalent in Asian countries compared with the developed countries. This prospective, randomised, open-label trial with blinded endpoint adjudication aims to evaluate the safety and efficacy of dabigatran for stroke prevention in AF patients with moderate or severe MS. Patients with AF aged &gt;= 18 years with moderate or severe MS not planned for valvular intervention in the coming 12 months will be randomised in a 1:1 ratio to receive dabigatran 110 mg or 150 mg two times per day or warfarin with international normalised ratio 2-3 in an open-label design. Patients with estimated creatinine clearance &lt;30 mL/min, or with a concomitant indication for antiplatelet therapy will be excluded. The primary outcome is a composite of stroke and systemic embolism. Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death. The estimated required sample size is approximately 686 participants. Ethics and dissemination The study protocol has been approved by the Institutional Review Board of the University of Hong Kong and Hong Kong West Cluster, Hospital Authority, Hong Kong for Fung Yiu King Hospital, Grantham Hospital, Queen Mary Hospital and Tung Wah Hospital in Hong Kong. Results will be published in peer-reviewed journals.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2020-038194</identifier><identifier>PMID: 32978200</identifier><language>eng</language><publisher>LONDON: Bmj Publishing Group</publisher><subject>Ablation ; Administration, Oral ; Adolescent ; Adult ; Anemia ; Anticoagulants ; Anticoagulants - adverse effects ; Atrial Fibrillation - complications ; Atrial Fibrillation - drug therapy ; Blood pressure ; Brain Ischemia - drug therapy ; Cardiac arrhythmia ; Cardiovascular disease ; Cardiovascular Medicine ; Clinical medicine ; Clinical trials ; Creatinine ; Dabigatran - adverse effects ; Disease prevention ; Drug dosages ; Embolisms ; Endocarditis ; General &amp; Internal Medicine ; Glycoproteins ; Hemoglobin ; Hong Kong ; Humans ; Hypertension ; Informed consent ; Ischemia ; Life expectancy ; Life Sciences &amp; Biomedicine ; Medicine, General &amp; Internal ; Mitral Valve Stenosis - complications ; Prospective Studies ; Prostheses ; Randomized Controlled Trials as Topic ; Science &amp; Technology ; Stroke ; Stroke - drug therapy ; Stroke - etiology ; Stroke - prevention &amp; control ; Thrombocytopenia ; Treatment Outcome</subject><ispartof>BMJ open, 2020-09, Vol.10 (9), p.e038194-e038194, Article 038194</ispartof><rights>Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2020 Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. 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Nonetheless, the safety and effectiveness of NOACs have not been evaluated in patients with AF with underlying moderate or severe mitral stenosis (MS), hence the recommended stroke prevention strategy remains warfarin therapy. Method and analysis MS remains disproportionately prevalent in Asian countries compared with the developed countries. This prospective, randomised, open-label trial with blinded endpoint adjudication aims to evaluate the safety and efficacy of dabigatran for stroke prevention in AF patients with moderate or severe MS. Patients with AF aged &gt;= 18 years with moderate or severe MS not planned for valvular intervention in the coming 12 months will be randomised in a 1:1 ratio to receive dabigatran 110 mg or 150 mg two times per day or warfarin with international normalised ratio 2-3 in an open-label design. Patients with estimated creatinine clearance &lt;30 mL/min, or with a concomitant indication for antiplatelet therapy will be excluded. The primary outcome is a composite of stroke and systemic embolism. Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death. The estimated required sample size is approximately 686 participants. Ethics and dissemination The study protocol has been approved by the Institutional Review Board of the University of Hong Kong and Hong Kong West Cluster, Hospital Authority, Hong Kong for Fung Yiu King Hospital, Grantham Hospital, Queen Mary Hospital and Tung Wah Hospital in Hong Kong. Results will be published in peer-reviewed journals.</description><subject>Ablation</subject><subject>Administration, Oral</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Anemia</subject><subject>Anticoagulants</subject><subject>Anticoagulants - adverse effects</subject><subject>Atrial Fibrillation - complications</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Blood pressure</subject><subject>Brain Ischemia - drug therapy</subject><subject>Cardiac arrhythmia</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular Medicine</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Creatinine</subject><subject>Dabigatran - adverse effects</subject><subject>Disease prevention</subject><subject>Drug dosages</subject><subject>Embolisms</subject><subject>Endocarditis</subject><subject>General &amp; Internal Medicine</subject><subject>Glycoproteins</subject><subject>Hemoglobin</subject><subject>Hong Kong</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Informed consent</subject><subject>Ischemia</subject><subject>Life expectancy</subject><subject>Life Sciences &amp; Biomedicine</subject><subject>Medicine, General &amp; Internal</subject><subject>Mitral Valve Stenosis - complications</subject><subject>Prospective Studies</subject><subject>Prostheses</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Science &amp; Technology</subject><subject>Stroke</subject><subject>Stroke - drug therapy</subject><subject>Stroke - etiology</subject><subject>Stroke - prevention &amp; control</subject><subject>Thrombocytopenia</subject><subject>Treatment Outcome</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>AOWDO</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>DOA</sourceid><recordid>eNqNkl1v0zAUhiMEYlPZL0BClrgZYgF_xUl2gVS1DCptYtJgt5Y_TopLahc7Hdpf4lfiflBtXJGbWM5zHp1z8hbFS4LfEcLEe71chBX4kmKKS8wa0vInxTHFnJcCV9XTB-ej4iSlBc4Pr9qqos-LI0bbuqEYHxe_r2MYggn9GYpqcMGrHpDyFllIbu5R6NB0rN1cDVF51IWIboYYfgC6jnALflOBZh6Nh-hUjy6cjq7vtyLkPLoKU8haQJs6uIMI6MplU58t4ENyCZ1Ox7ezaXl18-YcqdyDt2HpEtgztJ2vVxp6lIa1vX9RPOtUn-Bk_x4V3y4-fp18Li-_fJpNxpel4W07lFyYTqmmUwyE5oYabiytsW2YIlQJ2tVKaQuCEVFZ0jZK1FpDxTuGa8KFZqNitvPaoBZyFd1SxXsZlJPbixDnUsXBmR5krTBtGau0IB2HjjbWcs5Zq3ndKitYdn3YuVZrvQRr8sby9I-kj794913Ow52sK4qb7B4Vp3tBDD_XkAaZt2Mg79hDWCdJOReippyKjL7-B12Edcw_NFNCcEpom6MzKtiOMjGkFKE7NEOw3ERL7qMlN9GSu2jlqlcP5zjU_A1SBt7ugF-gQ5eMA2_ggOXsVXXuATf5RKpMN_9PT9ywDdQkrP3A_gCVee2T</recordid><startdate>20200925</startdate><enddate>20200925</enddate><creator>Zhou, Mi</creator><creator>Chan, Esther W.</creator><creator>Hai, Jo Jo</creator><creator>Wong, Chun Ka</creator><creator>Lau, Yuk Ming</creator><creator>Huang, Duo</creator><creator>Lam, Cheung Chi</creator><creator>Tam, Chor Cheung Frankie</creator><creator>Wong, Yiu Tung Anthony</creator><creator>Yung, See Yue Arthur</creator><creator>Chan, Ki Wan Kelvin</creator><creator>Feng, Yingqing</creator><creator>Tan, Ning</creator><creator>Chen, Ji-yan</creator><creator>Yung, Chi Yui</creator><creator>Lee, Kwok Lun</creator><creator>Choi, Chun Wai</creator><creator>Lam, Ho</creator><creator>Ng, Andrew</creator><creator>Fan, Katherine</creator><creator>Jim, Man Hong</creator><creator>Yiu, Kai Hang</creator><creator>Yan, Bryan P.</creator><creator>Siu, Chung Wah</creator><general>Bmj Publishing Group</general><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>AOWDO</scope><scope>BLEPL</scope><scope>DTL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-0864-9512</orcidid><orcidid>https://orcid.org/0000-0002-7602-9470</orcidid><orcidid>https://orcid.org/0000-0001-5205-9440</orcidid></search><sort><creationdate>20200925</creationdate><title>Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study</title><author>Zhou, Mi ; Chan, Esther W. ; Hai, Jo Jo ; Wong, Chun Ka ; Lau, Yuk Ming ; Huang, Duo ; Lam, Cheung Chi ; Tam, Chor Cheung Frankie ; Wong, Yiu Tung Anthony ; Yung, See Yue Arthur ; Chan, Ki Wan Kelvin ; Feng, Yingqing ; Tan, Ning ; Chen, Ji-yan ; Yung, Chi Yui ; Lee, Kwok Lun ; Choi, Chun Wai ; Lam, Ho ; Ng, Andrew ; Fan, Katherine ; Jim, Man Hong ; Yiu, Kai Hang ; Yan, Bryan P. ; Siu, Chung Wah</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c499t-46cfaa8fa3e6b4c2c4cd270d83a12a62f7aabde63165d198a67bbe54f307146b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Ablation</topic><topic>Administration, Oral</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Anemia</topic><topic>Anticoagulants</topic><topic>Anticoagulants - adverse effects</topic><topic>Atrial Fibrillation - complications</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Blood pressure</topic><topic>Brain Ischemia - drug therapy</topic><topic>Cardiac arrhythmia</topic><topic>Cardiovascular disease</topic><topic>Cardiovascular Medicine</topic><topic>Clinical medicine</topic><topic>Clinical trials</topic><topic>Creatinine</topic><topic>Dabigatran - adverse effects</topic><topic>Disease prevention</topic><topic>Drug dosages</topic><topic>Embolisms</topic><topic>Endocarditis</topic><topic>General &amp; Internal Medicine</topic><topic>Glycoproteins</topic><topic>Hemoglobin</topic><topic>Hong Kong</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Informed consent</topic><topic>Ischemia</topic><topic>Life expectancy</topic><topic>Life Sciences &amp; Biomedicine</topic><topic>Medicine, General &amp; Internal</topic><topic>Mitral Valve Stenosis - complications</topic><topic>Prospective Studies</topic><topic>Prostheses</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Science &amp; Technology</topic><topic>Stroke</topic><topic>Stroke - drug therapy</topic><topic>Stroke - etiology</topic><topic>Stroke - prevention &amp; control</topic><topic>Thrombocytopenia</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhou, Mi</creatorcontrib><creatorcontrib>Chan, Esther W.</creatorcontrib><creatorcontrib>Hai, Jo Jo</creatorcontrib><creatorcontrib>Wong, Chun Ka</creatorcontrib><creatorcontrib>Lau, Yuk Ming</creatorcontrib><creatorcontrib>Huang, Duo</creatorcontrib><creatorcontrib>Lam, Cheung Chi</creatorcontrib><creatorcontrib>Tam, Chor Cheung Frankie</creatorcontrib><creatorcontrib>Wong, Yiu Tung Anthony</creatorcontrib><creatorcontrib>Yung, See Yue Arthur</creatorcontrib><creatorcontrib>Chan, Ki Wan Kelvin</creatorcontrib><creatorcontrib>Feng, Yingqing</creatorcontrib><creatorcontrib>Tan, Ning</creatorcontrib><creatorcontrib>Chen, Ji-yan</creatorcontrib><creatorcontrib>Yung, Chi Yui</creatorcontrib><creatorcontrib>Lee, Kwok Lun</creatorcontrib><creatorcontrib>Choi, Chun Wai</creatorcontrib><creatorcontrib>Lam, Ho</creatorcontrib><creatorcontrib>Ng, Andrew</creatorcontrib><creatorcontrib>Fan, Katherine</creatorcontrib><creatorcontrib>Jim, Man Hong</creatorcontrib><creatorcontrib>Yiu, Kai Hang</creatorcontrib><creatorcontrib>Yan, Bryan P.</creatorcontrib><creatorcontrib>Siu, Chung Wah</creatorcontrib><collection>Web of Science - Science Citation Index Expanded - 2020</collection><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhou, Mi</au><au>Chan, Esther W.</au><au>Hai, Jo Jo</au><au>Wong, Chun Ka</au><au>Lau, Yuk Ming</au><au>Huang, Duo</au><au>Lam, Cheung Chi</au><au>Tam, Chor Cheung Frankie</au><au>Wong, Yiu Tung Anthony</au><au>Yung, See Yue Arthur</au><au>Chan, Ki Wan Kelvin</au><au>Feng, Yingqing</au><au>Tan, Ning</au><au>Chen, Ji-yan</au><au>Yung, Chi Yui</au><au>Lee, Kwok Lun</au><au>Choi, Chun Wai</au><au>Lam, Ho</au><au>Ng, Andrew</au><au>Fan, Katherine</au><au>Jim, Man Hong</au><au>Yiu, Kai Hang</au><au>Yan, Bryan P.</au><au>Siu, Chung Wah</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study</atitle><jtitle>BMJ open</jtitle><stitle>BMJ OPEN</stitle><addtitle>BMJ Open</addtitle><date>2020-09-25</date><risdate>2020</risdate><volume>10</volume><issue>9</issue><spage>e038194</spage><epage>e038194</epage><pages>e038194-e038194</pages><artnum>038194</artnum><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>Introduction Current international guidelines recommend non-vitamin K oral anticoagulants (NOACs) for stroke prevention among patients with non-valvular atrial fibrillation (AF) at significant ischaemic stroke risk given the superior safety and comparable efficacy of NOACs over warfarin. Nonetheless, the safety and effectiveness of NOACs have not been evaluated in patients with AF with underlying moderate or severe mitral stenosis (MS), hence the recommended stroke prevention strategy remains warfarin therapy. Method and analysis MS remains disproportionately prevalent in Asian countries compared with the developed countries. This prospective, randomised, open-label trial with blinded endpoint adjudication aims to evaluate the safety and efficacy of dabigatran for stroke prevention in AF patients with moderate or severe MS. Patients with AF aged &gt;= 18 years with moderate or severe MS not planned for valvular intervention in the coming 12 months will be randomised in a 1:1 ratio to receive dabigatran 110 mg or 150 mg two times per day or warfarin with international normalised ratio 2-3 in an open-label design. Patients with estimated creatinine clearance &lt;30 mL/min, or with a concomitant indication for antiplatelet therapy will be excluded. The primary outcome is a composite of stroke and systemic embolism. Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death. The estimated required sample size is approximately 686 participants. Ethics and dissemination The study protocol has been approved by the Institutional Review Board of the University of Hong Kong and Hong Kong West Cluster, Hospital Authority, Hong Kong for Fung Yiu King Hospital, Grantham Hospital, Queen Mary Hospital and Tung Wah Hospital in Hong Kong. Results will be published in peer-reviewed journals.</abstract><cop>LONDON</cop><pub>Bmj Publishing Group</pub><pmid>32978200</pmid><doi>10.1136/bmjopen-2020-038194</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-0864-9512</orcidid><orcidid>https://orcid.org/0000-0002-7602-9470</orcidid><orcidid>https://orcid.org/0000-0001-5205-9440</orcidid><oa>free_for_read</oa></addata></record>
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subjects Ablation
Administration, Oral
Adolescent
Adult
Anemia
Anticoagulants
Anticoagulants - adverse effects
Atrial Fibrillation - complications
Atrial Fibrillation - drug therapy
Blood pressure
Brain Ischemia - drug therapy
Cardiac arrhythmia
Cardiovascular disease
Cardiovascular Medicine
Clinical medicine
Clinical trials
Creatinine
Dabigatran - adverse effects
Disease prevention
Drug dosages
Embolisms
Endocarditis
General & Internal Medicine
Glycoproteins
Hemoglobin
Hong Kong
Humans
Hypertension
Informed consent
Ischemia
Life expectancy
Life Sciences & Biomedicine
Medicine, General & Internal
Mitral Valve Stenosis - complications
Prospective Studies
Prostheses
Randomized Controlled Trials as Topic
Science & Technology
Stroke
Stroke - drug therapy
Stroke - etiology
Stroke - prevention & control
Thrombocytopenia
Treatment Outcome
title Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study
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