RE-COVERY DVT/PE: Rationale and design of a prospective observational study of acute venous thromboembolism with a focus on dabigatran etexilate

Página do item simplificado
dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorAGENO, Walter
dc.contributor.authorCASELLA, Ivan B.
dc.contributor.authorHAN, Chee Kok
dc.contributor.authorRASKOB, Gary E.
dc.contributor.authorSCHELLONG, Sebastian
dc.contributor.authorSCHULMAN, Sam
dc.contributor.authorSINGER, Daniel E.
dc.contributor.authorKIMURA, Karen
dc.contributor.authorTANG, Wenbo
dc.contributor.authorDESCH, Marc
dc.contributor.authorGOLDHABER, Samuel Z.
dc.date.accessioned2018-09-13T15:27:45Z
dc.date.available2018-09-13T15:27:45Z
dc.date.issued2017
dc.description.abstractThe therapeutic management of venous thromboembolism (VTE) is rapidly evolving. Following the positive results of pivotal large-scale randomised trials, the non-vitamin K antagonist oral anticoagulants (NOACs) represent an important alternative to standard anticoagulation. In phase III studies, dabigatran was as effective as, and significantly safer than warfarin. Additional information on real-world data of dabigatran is now warranted. RE-COVERY DVT/PE is a multi-centre, international, observational (i.e. non-interventional) study enrolling patients with acute DVT and/or PE within 30 days after objective diagnosis. The study is designed with two phases. Phase 1 has a cross-sectional design, enrolling approximately 6000 patients independently of treatment choice, with the aim of providing a contemporary picture of the management of VIE worldwide. Phase 2 has a prospective cohort design, with follow-up of one year, enrolling 8000 patients treated with dabigatran or vitamin K antagonists (VKAs) with the aim of comparing their safety, defined by the occurrence of major bleeding, and effectiveness, defined by the occurrence of symptomatic recurrent VIE. RE-COVERY DVT/PE will complement both the results of other observational studies in this field and the results of phase Ill studies with dabigatran, in particular by assessing its clinical benefit in various patient subgroups treated in routine clinical practice.
dc.description.indexMEDLINE
dc.description.sponsorshipBayer
dc.description.sponsorshipBoehringer Ingelheim
dc.description.sponsorshipBMS
dc.description.sponsorshipDaiichi Sankyo
dc.description.sponsorshipJanssen
dc.description.sponsorshipJJ
dc.description.sponsorshipPfizer
dc.description.sponsorshipPortola
dc.description.sponsorshipEli Lilly
dc.description.sponsorshipBayer Healthcare
dc.identifier.citationTHROMBOSIS AND HAEMOSTASIS, v.117, n.2, p.415-421, 2017
dc.identifier.doi10.1160/TH16-07-0566
dc.identifier.issn0340-6245
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/28383
dc.language.isoeng
dc.publisherSCHATTAUER GMBH-VERLAG MEDIZIN NATURWISSENSCHAFTEN
dc.relation.ispartofThrombosis and Haemostasis
dc.rightsrestrictedAccess
dc.rights.holderCopyright SCHATTAUER GMBH-VERLAG MEDIZIN NATURWISSENSCHAFTEN
dc.subjectDeep-vein thrombosis
dc.subjectpulmonary embolism
dc.subjectdabigatran
dc.subjectanticoagulation
dc.subject.otherpulmonary-embolism
dc.subject.otheroral anticoagulants
dc.subject.otherantithrombotic therapy
dc.subject.otherthrombin inhibitor
dc.subject.otherwarfarin
dc.subject.otherguidelines
dc.subject.othermanagement
dc.subject.othertrials
dc.subject.otherrisk
dc.subject.wosHematology
dc.subject.wosPeripheral Vascular Disease
dc.titleRE-COVERY DVT/PE: Rationale and design of a prospective observational study of acute venous thromboembolism with a focus on dabigatran etexilate
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryMalásia
hcfmusp.affiliation.countryCanadá
hcfmusp.affiliation.countryItália
hcfmusp.affiliation.countryAlemanha
hcfmusp.affiliation.countryisoit
hcfmusp.affiliation.countryisomy
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisode
hcfmusp.affiliation.countryisoca
hcfmusp.author.externalAGENO, Walter:Univ Insubria, Varese, Italy
hcfmusp.author.externalHAN, Chee Kok:Univ Malaya, Kuala Lumpur, Malaysia
hcfmusp.author.externalRASKOB, Gary E.:Univ Oklahoma, Hlth Sci Ctr, Norman, OK 73019 USA
hcfmusp.author.externalSCHELLONG, Sebastian:Stadt Klinikum Dresden, Dresden, Germany
hcfmusp.author.externalSCHULMAN, Sam:Thrombosis & Atherosclerosis Res Inst, Hamilton, ON, Canada; McMaster Univ, Hamilton, ON, Canada
hcfmusp.author.externalSINGER, Daniel E.:Massachusetts Gen Hosp, Boston, MA 02114 USA; Harvard Med Sch, Boston, MA USA
hcfmusp.author.externalKIMURA, Karen:Boehringer Ingelheim Canada, Burlington, ON, Canada
hcfmusp.author.externalTANG, Wenbo:Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany
hcfmusp.author.externalDESCH, Marc:Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany
hcfmusp.author.externalGOLDHABER, Samuel Z.:Harvard Med Sch, Boston, MA USA; Brigham & Womens Hosp, 75 Francis St, Boston, MA 02115 USA
hcfmusp.citation.scopus15
hcfmusp.contributor.author-fmusphcIVAN BENADUCE CASELLA
hcfmusp.description.beginpage415
hcfmusp.description.endpage421
hcfmusp.description.issue2
hcfmusp.description.volume117
hcfmusp.origemWOS
hcfmusp.origem.pubmed27853808
hcfmusp.origem.scopus2-s2.0-85011092085
hcfmusp.origem.wosWOS:000393358700023
hcfmusp.publisher.citySTUTTGART
hcfmusp.publisher.countryGERMANY
hcfmusp.relation.referenceAgeno W, 2016, LANCET HAEMATOL, V3, pE12, DOI 10.1016/S2352-3026(15)00257-4
hcfmusp.relation.referenceAgeno W, 2012, CHEST, V141, pE44S, DOI 10.1378/chest.11-2292
hcfmusp.relation.referenceBeyer-Westendorf J, 2015, THROMB HAEMOSTASIS, V113, P231, DOI 10.1160/TH14-06-0484
hcfmusp.relation.referenceDentali F, 2016, THROMB HAEMOSTASIS, V115, P399, DOI 10.1160/TH15-02-0172
hcfmusp.relation.referenceEisert WG, 2010, ARTERIOSCL THROM VAS, V30, P1885, DOI 10.1161/ATVBAHA.110.203604
hcfmusp.relation.referenceGraham DJ, 2015, CIRCULATION, V131, P157, DOI 10.1161/CIRCULATIONAHA.114.012061
hcfmusp.relation.referenceHankey GJ, 2011, CIRCULATION, V123, P1436, DOI 10.1161/CIRCULATIONAHA.110.004424
hcfmusp.relation.referenceHuisman MV, 2014, AM HEART J, V167, P329, DOI 10.1016/j.ahj.2013.12.006
hcfmusp.relation.referenceKearon C, 2016, CHEST, V149, P315, DOI 10.1016/j.chest.2015.11.026
hcfmusp.relation.referenceKearon C, 2012, CHEST, V141, pE419S, DOI 10.1378/chest.11-2301
hcfmusp.relation.referenceKonstantinides SV, 2015, THROMB HAEMOSTASIS, V113, P1202, DOI 10.1160/TH14-11-0998
hcfmusp.relation.referenceKonstantinides SV, 2014, EUR HEART J, V35, P3033, DOI 10.1093/eurheartj/ehu283
hcfmusp.relation.referenceLecumberri R, 2013, THROMB HAEMOSTASIS, V110, P834, DOI 10.1160/TH13-02-0132
hcfmusp.relation.referenceLinkins LA, 2003, ANN INTERN MED, V139, P893, DOI 10.7326/0003-4819-139-11-200312020-00007
hcfmusp.relation.referencePengo V, 2004, NEW ENGL J MED, V350, P2257, DOI 10.1056/NEJMoa032274
hcfmusp.relation.referencePrandoni P, 2007, HAEMATOL-HEMATOL J, V92, P199, DOI 10.3324/haematol.10516
hcfmusp.relation.referencePrandoni P, 2009, BRIT J HAEMATOL, V145, P286, DOI 10.1111/j.1365-2141.2009.07601.x
hcfmusp.relation.referenceRaskob GE, 2014, J THROMB HAEMOST, V12, P1580, DOI 10.1111/jth.12698
hcfmusp.relation.referenceSardar P, 2013, DRUGS, V73, P1171, DOI 10.1007/s40265-013-0082-7
hcfmusp.relation.referenceSchulman S., 2014, SCI STAND COMM M IST, V12, P1
hcfmusp.relation.referenceSchulman S, 2014, BLOOD, V124
hcfmusp.relation.referenceSchulman S, 2013, BLOOD, V122
hcfmusp.relation.referenceSchulman S, 2013, BLOOD, V122
hcfmusp.relation.referenceSchulman S, 2013, BLOOD, V122
hcfmusp.relation.referenceSchulman S, 2014, CIRCULATION, V129, P764, DOI 10.1161/CIRCULATIONAHA.113.004450
hcfmusp.relation.referenceSchulman S, 2013, NEW ENGL J MED, V368, P709, DOI 10.1056/NEJMoa1113697
hcfmusp.relation.referenceSchulman S, 2009, NEW ENGL J MED, V361, P2342, DOI 10.1056/NEJMoa0906598
hcfmusp.relation.referenceStangier J, 2007, BRIT J CLIN PHARMACO, V64, P292, DOI 10.1111/j.1365-2125.2007.02899.x
hcfmusp.relation.referenceStangier J, 2009, CLIN APPL THROMB-HEM, V15, p9S, DOI 10.1177/1076029609343004
hcfmusp.relation.referencevan Es N, 2014, BLOOD, V124, P1968, DOI [10.1182/blood-2014-04571232, 10.1182/blood-2014-04-571232]
hcfmusp.scopus.lastupdate2024-05-10
relation.isAuthorOfPublicationc37bc428-6bc7-47a0-b6e6-1dd1e4d26bd1
relation.isAuthorOfPublication.latestForDiscoveryc37bc428-6bc7-47a0-b6e6-1dd1e4d26bd1
Arquivos
Pacote Original
Agora exibindo 1 - 1 de 1
Nenhuma Miniatura disponível
Nome:
art_AGENO_RECOVERY_DVTPE_Rationale_and_design_of_a_prospective_2017.PDF
Tamanho:
224.46 KB
Formato:
Adobe Portable Document Format
Descrição:
publishedVersion (English)
Baixar
Coleções
Artigos e Materiais de Revistas Científicas - HC/ICHC
Artigos e Materiais de Revistas Científicas - LIM/02
Artigos e Materiais de Revistas Científicas - ODS/03