Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively: protocol
Warfarin and similar vitamin K antagonists have been the standard therapy for patients with mechanical or biological valve prosthesis and atrial fibrillation (AF). Even with the appropriate use of therapy, some studies have reported that there is a high incidence of thromboembolic events, 1%-4% per...
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| creator | Duraes, Andre Rodrigues Roriz, Pollianna Ds Bulhoes, Fabio V Nunes, Bianca DA Muniz, Juliana Qv Neto, Italvar Ndcr Fernandes, Andre Ms Reis, Francisco Jfbd Camara, Edmundo Jn Junior, Erenaldo Dsr Segundo, Deusdeth Ts Silva, Felipe Pinho E Albuquerque Aras, Roque |
| description | Warfarin and similar vitamin K antagonists have been the standard therapy for patients with mechanical or biological valve prosthesis and atrial fibrillation (AF). Even with the appropriate use of therapy, some studies have reported that there is a high incidence of thromboembolic events, 1%-4% per year. Furthermore, a bleeding risk is significant, ranging from 2% to 9% per year, according to some studies.
The objective of our study was to examine the effect of dabigatran etexilate versus dose-adjusted warfarin for the prevention of intracardiac thrombus in persistent or permanent AF at least 3 months after aortic and/or mitral bioprosthesis replacement.
Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively (DAWA) is a phase 2, prospective, open label, randomized exploratory pilot study. The main variable to be observed in this study is intracardiac thrombus. From August 2013 to April 2015, 100 patients, at least 3 months after aortic and/or mitral bioprosthesis replacement and permanent or persistent AF postoperatively, who match eligibility criteria will be selected from Ana Nery Hospital in Salvador-Bahia with a follow-up of three months. Patients were randomly assigned in a 1:1 ratio to receive either dabigatran etexilate or warfarin.
Although the present study has no statistic power to proof non-inferiority, it is expected that the dabigatran etexilate group will be protected as well as the warfarin group from intracardiac thrombus, without increasing the bleeding rates, since we are using safer doses (110 mg bid). The lack of necessity of monitoring INR is also another factor that contributes to a better adherence to the new drug and it can make all the difference in the manner of doing anticoagulation for patients with similar clinical characteristics.
The study is in the recruitment phase. It is possible that dabigatran etexilate is as effective as warfarin in preventing the emergence of intracardiac thrombus in patients with AF and mitral and/or aortic bioprosthesis.
Clinicaltrials.gov NCT01868243; http://clinicaltrials.gov/ct2/show/NCT01868243 (Archived by WebCite at http://www.webcitation/6OABiuasd). |
| doi_str_mv | 10.2196/resprot.3014 |
| format | Article |
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The objective of our study was to examine the effect of dabigatran etexilate versus dose-adjusted warfarin for the prevention of intracardiac thrombus in persistent or permanent AF at least 3 months after aortic and/or mitral bioprosthesis replacement.
Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively (DAWA) is a phase 2, prospective, open label, randomized exploratory pilot study. The main variable to be observed in this study is intracardiac thrombus. From August 2013 to April 2015, 100 patients, at least 3 months after aortic and/or mitral bioprosthesis replacement and permanent or persistent AF postoperatively, who match eligibility criteria will be selected from Ana Nery Hospital in Salvador-Bahia with a follow-up of three months. Patients were randomly assigned in a 1:1 ratio to receive either dabigatran etexilate or warfarin.
Although the present study has no statistic power to proof non-inferiority, it is expected that the dabigatran etexilate group will be protected as well as the warfarin group from intracardiac thrombus, without increasing the bleeding rates, since we are using safer doses (110 mg bid). The lack of necessity of monitoring INR is also another factor that contributes to a better adherence to the new drug and it can make all the difference in the manner of doing anticoagulation for patients with similar clinical characteristics.
The study is in the recruitment phase. It is possible that dabigatran etexilate is as effective as warfarin in preventing the emergence of intracardiac thrombus in patients with AF and mitral and/or aortic bioprosthesis.
Clinicaltrials.gov NCT01868243; http://clinicaltrials.gov/ct2/show/NCT01868243 (Archived by WebCite at http://www.webcitation/6OABiuasd).</description><identifier>ISSN: 1929-0748</identifier><identifier>EISSN: 1929-0748</identifier><identifier>EISSN: 1438-8871</identifier><identifier>DOI: 10.2196/resprot.3014</identifier><identifier>PMID: 24691436</identifier><language>eng</language><publisher>Canada: Gunther Eysenbach MD MPH, Associate Professor</publisher><subject>Anticoagulants ; Atrial fibrillation ; Bleeding ; Blood clots ; Cardiac arrhythmia ; Drug dosages ; Electrocardiography ; Embolisms ; FDA approval ; Heart ; Hemoglobin ; Nervous system ; Patient safety ; Pharmacokinetics ; Prostheses ; Prosthesis ; Protocol ; Recruitment ; Stroke ; Thromboembolism ; Thrombosis ; Vitamin K ; Warfarin</subject><ispartof>JMIR research protocols, 2014-04, Vol.3 (2), p.e21-e21</ispartof><rights>2014. This work is licensed under http://creativecommons.org/licenses/by/2.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Andre Rodrigues Duraes, Pollianna DS Roriz, Fabio V Bulhoes, Bianca DA Nunes, Juliana QV Muniz, Italvar NDCR Neto, Andre MS Fernandes, Francisco JFBD Reis, Edmundo JN Camara, Erenaldo DSR Junior, Deusdeth TS Segundo, Felipe Pinho E Albuquerque Silva, Roque Aras. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.04.2014. 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c402t-71d77133cf676f900de6f3f05fc1f0c5ae85c0927fd8128275f4cc49a44087ce3</citedby><cites>FETCH-LOGICAL-c402t-71d77133cf676f900de6f3f05fc1f0c5ae85c0927fd8128275f4cc49a44087ce3</cites><orcidid>0000-0002-7966-8550 ; 0000-0002-1506-0327 ; 0000-0002-5705-4777</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4004148/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4004148/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27903,27904,30978,53770,53772</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24691436$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Duraes, Andre Rodrigues</creatorcontrib><creatorcontrib>Roriz, Pollianna Ds</creatorcontrib><creatorcontrib>Bulhoes, Fabio V</creatorcontrib><creatorcontrib>Nunes, Bianca DA</creatorcontrib><creatorcontrib>Muniz, Juliana Qv</creatorcontrib><creatorcontrib>Neto, Italvar Ndcr</creatorcontrib><creatorcontrib>Fernandes, Andre Ms</creatorcontrib><creatorcontrib>Reis, Francisco Jfbd</creatorcontrib><creatorcontrib>Camara, Edmundo Jn</creatorcontrib><creatorcontrib>Junior, Erenaldo Dsr</creatorcontrib><creatorcontrib>Segundo, Deusdeth Ts</creatorcontrib><creatorcontrib>Silva, Felipe Pinho E Albuquerque</creatorcontrib><creatorcontrib>Aras, Roque</creatorcontrib><title>Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively: protocol</title><title>JMIR research protocols</title><addtitle>JMIR Res Protoc</addtitle><description>Warfarin and similar vitamin K antagonists have been the standard therapy for patients with mechanical or biological valve prosthesis and atrial fibrillation (AF). Even with the appropriate use of therapy, some studies have reported that there is a high incidence of thromboembolic events, 1%-4% per year. Furthermore, a bleeding risk is significant, ranging from 2% to 9% per year, according to some studies.
The objective of our study was to examine the effect of dabigatran etexilate versus dose-adjusted warfarin for the prevention of intracardiac thrombus in persistent or permanent AF at least 3 months after aortic and/or mitral bioprosthesis replacement.
Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively (DAWA) is a phase 2, prospective, open label, randomized exploratory pilot study. The main variable to be observed in this study is intracardiac thrombus. From August 2013 to April 2015, 100 patients, at least 3 months after aortic and/or mitral bioprosthesis replacement and permanent or persistent AF postoperatively, who match eligibility criteria will be selected from Ana Nery Hospital in Salvador-Bahia with a follow-up of three months. Patients were randomly assigned in a 1:1 ratio to receive either dabigatran etexilate or warfarin.
Although the present study has no statistic power to proof non-inferiority, it is expected that the dabigatran etexilate group will be protected as well as the warfarin group from intracardiac thrombus, without increasing the bleeding rates, since we are using safer doses (110 mg bid). The lack of necessity of monitoring INR is also another factor that contributes to a better adherence to the new drug and it can make all the difference in the manner of doing anticoagulation for patients with similar clinical characteristics.
The study is in the recruitment phase. It is possible that dabigatran etexilate is as effective as warfarin in preventing the emergence of intracardiac thrombus in patients with AF and mitral and/or aortic bioprosthesis.
Clinicaltrials.gov NCT01868243; http://clinicaltrials.gov/ct2/show/NCT01868243 (Archived by WebCite at http://www.webcitation/6OABiuasd).</description><subject>Anticoagulants</subject><subject>Atrial fibrillation</subject><subject>Bleeding</subject><subject>Blood clots</subject><subject>Cardiac arrhythmia</subject><subject>Drug dosages</subject><subject>Electrocardiography</subject><subject>Embolisms</subject><subject>FDA approval</subject><subject>Heart</subject><subject>Hemoglobin</subject><subject>Nervous system</subject><subject>Patient safety</subject><subject>Pharmacokinetics</subject><subject>Prostheses</subject><subject>Prosthesis</subject><subject>Protocol</subject><subject>Recruitment</subject><subject>Stroke</subject><subject>Thromboembolism</subject><subject>Thrombosis</subject><subject>Vitamin 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postoperatively: protocol</title><author>Duraes, Andre Rodrigues ; Roriz, Pollianna Ds ; Bulhoes, Fabio V ; Nunes, Bianca DA ; Muniz, Juliana Qv ; Neto, Italvar Ndcr ; Fernandes, Andre Ms ; Reis, Francisco Jfbd ; Camara, Edmundo Jn ; Junior, Erenaldo Dsr ; Segundo, Deusdeth Ts ; Silva, Felipe Pinho E Albuquerque ; Aras, Roque</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c402t-71d77133cf676f900de6f3f05fc1f0c5ae85c0927fd8128275f4cc49a44087ce3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Anticoagulants</topic><topic>Atrial fibrillation</topic><topic>Bleeding</topic><topic>Blood clots</topic><topic>Cardiac arrhythmia</topic><topic>Drug dosages</topic><topic>Electrocardiography</topic><topic>Embolisms</topic><topic>FDA approval</topic><topic>Heart</topic><topic>Hemoglobin</topic><topic>Nervous system</topic><topic>Patient safety</topic><topic>Pharmacokinetics</topic><topic>Prostheses</topic><topic>Prosthesis</topic><topic>Protocol</topic><topic>Recruitment</topic><topic>Stroke</topic><topic>Thromboembolism</topic><topic>Thrombosis</topic><topic>Vitamin K</topic><topic>Warfarin</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Duraes, Andre Rodrigues</creatorcontrib><creatorcontrib>Roriz, Pollianna Ds</creatorcontrib><creatorcontrib>Bulhoes, Fabio V</creatorcontrib><creatorcontrib>Nunes, Bianca DA</creatorcontrib><creatorcontrib>Muniz, Juliana Qv</creatorcontrib><creatorcontrib>Neto, Italvar Ndcr</creatorcontrib><creatorcontrib>Fernandes, Andre Ms</creatorcontrib><creatorcontrib>Reis, Francisco Jfbd</creatorcontrib><creatorcontrib>Camara, Edmundo Jn</creatorcontrib><creatorcontrib>Junior, Erenaldo Dsr</creatorcontrib><creatorcontrib>Segundo, Deusdeth Ts</creatorcontrib><creatorcontrib>Silva, Felipe Pinho E Albuquerque</creatorcontrib><creatorcontrib>Aras, Roque</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Applied Social Sciences Index & Abstracts (ASSIA)</collection><collection>Library & Information Sciences Abstracts (LISA) - CILIP Edition</collection><collection>Library & Information Sciences Abstracts (LISA)</collection><collection>Library & Information Science Abstracts (LISA)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 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research protocols</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Duraes, Andre Rodrigues</au><au>Roriz, Pollianna Ds</au><au>Bulhoes, Fabio V</au><au>Nunes, Bianca DA</au><au>Muniz, Juliana Qv</au><au>Neto, Italvar Ndcr</au><au>Fernandes, Andre Ms</au><au>Reis, Francisco Jfbd</au><au>Camara, Edmundo Jn</au><au>Junior, Erenaldo Dsr</au><au>Segundo, Deusdeth Ts</au><au>Silva, Felipe Pinho E Albuquerque</au><au>Aras, Roque</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively: protocol</atitle><jtitle>JMIR research protocols</jtitle><addtitle>JMIR Res Protoc</addtitle><date>2014-04-01</date><risdate>2014</risdate><volume>3</volume><issue>2</issue><spage>e21</spage><epage>e21</epage><pages>e21-e21</pages><issn>1929-0748</issn><eissn>1929-0748</eissn><eissn>1438-8871</eissn><abstract>Warfarin and similar vitamin K antagonists have been the standard therapy for patients with mechanical or biological valve prosthesis and atrial fibrillation (AF). Even with the appropriate use of therapy, some studies have reported that there is a high incidence of thromboembolic events, 1%-4% per year. Furthermore, a bleeding risk is significant, ranging from 2% to 9% per year, according to some studies.
The objective of our study was to examine the effect of dabigatran etexilate versus dose-adjusted warfarin for the prevention of intracardiac thrombus in persistent or permanent AF at least 3 months after aortic and/or mitral bioprosthesis replacement.
Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively (DAWA) is a phase 2, prospective, open label, randomized exploratory pilot study. The main variable to be observed in this study is intracardiac thrombus. From August 2013 to April 2015, 100 patients, at least 3 months after aortic and/or mitral bioprosthesis replacement and permanent or persistent AF postoperatively, who match eligibility criteria will be selected from Ana Nery Hospital in Salvador-Bahia with a follow-up of three months. Patients were randomly assigned in a 1:1 ratio to receive either dabigatran etexilate or warfarin.
Although the present study has no statistic power to proof non-inferiority, it is expected that the dabigatran etexilate group will be protected as well as the warfarin group from intracardiac thrombus, without increasing the bleeding rates, since we are using safer doses (110 mg bid). The lack of necessity of monitoring INR is also another factor that contributes to a better adherence to the new drug and it can make all the difference in the manner of doing anticoagulation for patients with similar clinical characteristics.
The study is in the recruitment phase. It is possible that dabigatran etexilate is as effective as warfarin in preventing the emergence of intracardiac thrombus in patients with AF and mitral and/or aortic bioprosthesis.
Clinicaltrials.gov NCT01868243; http://clinicaltrials.gov/ct2/show/NCT01868243 (Archived by WebCite at http://www.webcitation/6OABiuasd).</abstract><cop>Canada</cop><pub>Gunther Eysenbach MD MPH, Associate Professor</pub><pmid>24691436</pmid><doi>10.2196/resprot.3014</doi><orcidid>https://orcid.org/0000-0002-7966-8550</orcidid><orcidid>https://orcid.org/0000-0002-1506-0327</orcidid><orcidid>https://orcid.org/0000-0002-5705-4777</orcidid><oa>free_for_read</oa></addata></record> |
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| source | DOAJ Directory of Open Access Journals; PubMed Central Open Access; Applied Social Sciences Index & Abstracts (ASSIA); EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Anticoagulants Atrial fibrillation Bleeding Blood clots Cardiac arrhythmia Drug dosages Electrocardiography Embolisms FDA approval Heart Hemoglobin Nervous system Patient safety Pharmacokinetics Prostheses Prosthesis Protocol Recruitment Stroke Thromboembolism Thrombosis Vitamin K Warfarin |
| title | Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively: protocol |
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