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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003069-25 | EudraCT Number |
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There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a VKA-based antithrombotic regimen in subjects with AF following catheter ablation. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edoxaban-based regimen | Experimental | Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period. |
|
| VKA-based regimen | Active Comparator | VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edoxaban | Drug | Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced the Composite of All-cause Death, Stroke (VARC-2), and Major Bleeding (ISTH) in the Edoxaban Group Compared With Vitamin K Antagonist (VKA) Group in Participants Undergoing Catheter Ablation (Adjudicated Data) | Stroke (ischemic, hemorrhagic, or undetermined) was defined by Valve Academic Research Consortium-2 (VARC-2) as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury following hemorrhage or infarction. A stroke event was based on any of the following: duration of neurological dysfunction >24 hours (h), duration of neurological dysfunction <24 h in case of imaging-documented new hemorrhage or infarction, and a neurological dysfunction resulting in death. Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability. | Day 1 to Day 90 |
| Number of Participants Who Experienced Major Bleeding (International Society on Thrombosis and Hemostasis [ISTH]) in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data) | Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability. | Day 1 to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced the Composite of All-cause Death, Stroke (Alternative), and Major Bleeding (ISTH) in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data) | An alternative definition characterized stroke (ischemic, hemorrhagic, or undetermined) as an abrupt onset, over minutes to hours, of a focal neurological deficit in the distribution of a single brain artery that was not due to an identifiable nonvascular cause (ie, brain tumor or trauma), and that either lasted at least 24 hours or resulted in death within 24 hours of onset. Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Middelheim | Antwerp | 2020 | Belgium | |||
| Erasme Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24251359 | Background | Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19. | |
| 27567465 |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU), US and/or Japan marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Participants were required to have completed between 21 to 28 days of anticoagulation with study treatment prior to the catheter ablation visit/periprocedural visit (Day 0).
A total of 614 participants who met the inclusion and none of the exclusion criteria were randomized; 602 received study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Edoxaban-based Regimen | Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period. Edoxaban: Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects. |
| FG001 | VKA-based Regimen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2017 |
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| VKA-Based Regimen | Drug | Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, United Kingdom (UK), Taiwan and Korea. |
|
|
| VKA-Based Regimen | Drug | Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands. |
|
|
| VKA-Based Regimen | Drug | Dosed at INR levels. Standard of Care treatment in France. |
|
|
| VKA-Based Regimen | Drug | Dosed at INR levels. Standard of Care treatment in Spain. |
|
|
| Day 1 to Day 90 |
| Number of Participants Who Experienced the Composite of Stroke (VARC-2), Systemic Embolic Events (SEE), and Cardiovascular (CV) Mortality in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data) | Stroke (ischemic, hemorrhagic, or undetermined) was defined by Valve Academic Research Consortium-2 (VARC-2) as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury following hemorrhage or infarction. A stroke event was based on any of the following: duration of neurological dysfunction >24 hours (h), duration of neurological dysfunction <24 h in case of imaging-documented new hemorrhage or infarction, and a neurological dysfunction resulting in death. SEE was defined as an arterial embolism resulting in clinical ischemia, excluding the central nervous system, coronary, and pulmonary arterial circulation. CV mortality was defined as cardiac or vascular death according to Academic Research Consortium. | Day 1 to Day 90 |
| Brussels |
| 1070 |
| Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| University of Calgary | Calgary | T2N 4Z6 | Canada |
| Hamilton Health Sciences/McMaster University | Hamilton | L8L 2X2 | Canada |
| Montreal Heart Institute | Montreal | H1T 1C8 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | J1H 5N4 | Canada |
| FN Brno | Brno | 625 00 | Czechia |
| St. Anne's University Hospital Brno, International Clinical Research Center | Brno | 69691 | Czechia |
| FN Kralovske Vinohrady | Prague | 100 34 | Czechia |
| VFN v Praze II. Internà klinika - Kardiologie a angiologie | Prague | 128 08 | Czechia |
| IKEM | Prague | 14021 | Czechia |
| University Hospital Motol - Cardiology | Prague | 150 06 | Czechia |
| Masarykova nemocnice - Kardiologie Krajská zdravotnÃ, a.s. | Ústà nad Labem | 40113 | Czechia |
| Universitäts Herzzentrum Freiburg-Bad Krozingen Klinik für Kardiologie und Angiologie II | Bad Krozingen | 79189 | Germany |
| Charité Universitätsmedizin Berlin - CVK Medizinische Klinik m.S. Kardiologie | Berlin | 13353 | Germany |
| Klinikum Bielefeld Klinik für Kardiologie/internist. Intensivmedizin | Bielefeld | 33604 | Germany |
| Klinikum Coburg GmbH II.Med.Klinik | Coburg | 96450 | Germany |
| Klinik für Innere Medizin I | Dortmund | 44137 | Germany |
| University Clinic Duesseldorf Clinic for Cardiology, Pneumology and Angiology | Düsseldorf | 40225 | Germany |
| Universitäres Herzzentrum Hamburg Kardiologie mit Schwerpunkt Elektrophysiologie | Hamburg | 20251 | Germany |
| University Hospital of Heidelberg Clinic of Cardiology, Angiology and Pneumology | Heidelberg | 69120 | Germany |
| Herzzentrum Leipzig - Universitätsklinik Abteilung für Rhythmologie | Leipzig | 04289 | Germany |
| Univ. of Muenster.Cardiovascular Medicine | Münster | 48149 | Germany |
| Universitätsmedizin Rostock Zentrum für Innere Medizin I, Kardiologie | Rostock | 18057 | Germany |
| Deutsches Herzk. Universitätsklinikum Tübingen Medizinische Klinik III. Kardiologie | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I | Würzburg | 97080 | Germany |
| Semmelweis Egyetem Városmajori SzÃv- és Érgyógyászati Klinika | Budapest | 1122 | Hungary |
| Magyar Honvédség Egészségügyi Központ Kardiológiai Osztály | Budapest | 1134 | Hungary |
| Debreceni Egyetem Kardiológiai és SzÃvsebészeti Klinika | Debrecen | 4032 | Hungary |
| Pecs University Clinical Center | Pécs | H 7624 | Hungary |
| Szegedi Tudományegyetem II. Belgyógyászati Klnika és Kardiológiai Központ | Szeged | 6725 | Hungary |
| Zala Megyei Szent Rafael Kórház Kardiológia Osztály | Zalaegerszeg | 8900 | Hungary |
| Ospedale San Donato | Arezzo | 52100 | Italy |
| Pineta Grande Hospital | Castel Volturno | 81030 | Italy |
| Universita' degli Studi Catanzaro | Catanzaro | 88100 | Italy |
| Arcispedale Sant'Anna | Cona | 44124 | Italy |
| Azienda USL Toscana | Florence | 50122 | Italy |
| Ospedale della Misericordia | Grosseto | 58100 | Italy |
| Ospedale dell'Angelo | Mestre | 30174 | Italy |
| ASST Vimercate | Monza | 80082 | Italy |
| Ospedale Santo Cuore | Negrar | 37024 | Italy |
| Istituto di Cura cittè di Pavia | Pavia | 27100 | Italy |
| Azienda Ospedaliera di Piacenza "Ospedale Guglielmo d Saliceto" | Piacenza | 29124 | Italy |
| Policlinico Casilino | Roma | 00169 | Italy |
| Largo Agostino Gemelli | Rome | 00168 | Italy |
| Ospedale Ecclesiastico "Miulli" | Sant'Eramo | 70021 | Italy |
| University Hospital - Szpital Uniwersytecki | Krakow | 31-501 | Poland |
| Klinika Intensywnej Terapii Kardiologicznej | Lodz | 92-213 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 4 Klinika Kardiologii | Lublin | 20-954 | Poland |
| Oddzial Kardiologii Szpital Grochowski im. dr R. Masztaka SPZOZ | Warsaw | 04-073 | Poland |
| Oddział Kliniczny Kardiologii SUM Katedra Kardiologii | Zabrze | 41-800 | Poland |
| Samsung Medical Center | Seoul | Gangnam-gu | 06351 | South Korea |
| Seoul National University Hospital | Seoul | Jongno-gu | 03080 | South Korea |
| Yonsei University Severance Hospital | Seoul | Seodaemun-Gu | 03722 | South Korea |
| Korea University Anam Hospital | Seoul | Seoungbuk-gu | 02841 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Hospital General Universitario | Alicante | 03540 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Clinic Cardiologia | Barcelona | 8036 | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario San Juan de Alicante | Sant Joan d'Alacant | 03550 | Spain |
| Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital (VGH-TC) | Taichung | 40705 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Chang Gung Memorial Hospital | Taoyuan City | 33305 | Taiwan |
| Blackpool Teaching Hospitals NHS | Blackpool | FY3 8NR | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Papworth Hospital NHS Trust | Cambridge | CB23 3RE | United Kingdom |
| Leeds General Infirmary | Leeds | LS1 3EX | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Background |
| Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P, Agewall S, Camm J, Baron Esquivias G, Budts W, Carerj S, Casselman F, Coca A, De Caterina R, Deftereos S, Dobrev D, Ferro JM, Filippatos G, Fitzsimons D, Gorenek B, Guenoun M, Hohnloser SH, Kolh P, Lip GY, Manolis A, McMurray J, Ponikowski P, Rosenhek R, Ruschitzka F, Savelieva I, Sharma S, Suwalski P, Tamargo JL, Taylor CJ, Van Gelder IC, Voors AA, Windecker S, Zamorano JL, Zeppenfeld K. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016 Nov;18(11):1609-1678. doi: 10.1093/europace/euw295. Epub 2016 Aug 27. No abstract available. |
| 19864188 | Background | Crawford T, Oral H. Current status and outcomes of catheter ablation for atrial fibrillation. Heart Rhythm. 2009 Dec;6(12 Suppl):S12-7. doi: 10.1016/j.hrthm.2009.07.026. Epub 2009 Oct 23. |
| 19968920 | Background | Hussein AA, Martin DO, Saliba W, Patel D, Karim S, Batal O, Banna M, Williams-Andrews M, Sherman M, Kanj M, Bhargava M, Dresing T, Callahan T, Tchou P, Di Biase L, Beheiry S, Lindsay B, Natale A, Wazni O. Radiofrequency ablation of atrial fibrillation under therapeutic international normalized ratio: a safe and efficacious periprocedural anticoagulation strategy. Heart Rhythm. 2009 Oct;6(10):1425-9. doi: 10.1016/j.hrthm.2009.07.007. Epub 2009 Jul 10. |
| 25975659 | Background | Cappato R, Marchlinski FE, Hohnloser SH, Naccarelli GV, Xiang J, Wilber DJ, Ma CS, Hess S, Wells DS, Juang G, Vijgen J, Hugl BJ, Balasubramaniam R, De Chillou C, Davies DW, Fields LE, Natale A; VENTURE-AF Investigators. Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation. Eur Heart J. 2015 Jul 21;36(28):1805-11. doi: 10.1093/eurheartj/ehv177. Epub 2015 May 14. |
| 24569891 | Background | Chen J, Todd DM, Hocini M, Larsen TB, Bongiorni MG, Blomstrom-Lundqvist C; Scientific Initiative Committee, European Heart Rhythm Association. Current periprocedural management of ablation for atrial fibrillation in Europe: results of the European Heart Rhythm Association survey. Europace. 2014 Mar;16(3):378-81. doi: 10.1093/europace/euu043. |
| 23991658 | Background | Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31. |
| 19995881 | Background | Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7. |
| 33249467 | Derived | Hohnloser SH, Camm AJ, Cappato R, Diener HC, Heidbuchel H, Mont L, Morillo CA, Lanz HJ, Rauer H, Reimitz PE, Smolnik R, Kautzner J. Periprocedural anticoagulation in the uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation (ELIMINATE-AF) trial. Europace. 2021 Jan 27;23(1):65-72. doi: 10.1093/europace/euaa199. |
| 29663464 | Derived | Hohnloser SH, Camm J, Cappato R, Diener HC, Heidbuchel H, Lanz HJ, Mont L, Morillo CA, Smolnik R, Yin OQP, Kautzner J. Uninterrupted administration of edoxaban vs vitamin K antagonists in patients undergoing atrial fibrillation catheter ablation: Rationale and design of the ELIMINATE-AF study. Clin Cardiol. 2018 Apr;41(4):440-449. doi: 10.1002/clc.22918. Epub 2018 Apr 17. |
VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)
VKA-Based Regimen: Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, UK, Taiwan and Korea.
VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.
VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in France.
VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Spain.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Edoxaban-based Regimen | Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period. Edoxaban: Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects. |
| BG001 | VKA-based Regimen | VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen) VKA-Based Regimen: Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, United Kingdon (UK), Taiwan and Korea. VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands. VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in France. VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Spain. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced the Composite of All-cause Death, Stroke (VARC-2), and Major Bleeding (ISTH) in the Edoxaban Group Compared With Vitamin K Antagonist (VKA) Group in Participants Undergoing Catheter Ablation (Adjudicated Data) | Stroke (ischemic, hemorrhagic, or undetermined) was defined by Valve Academic Research Consortium-2 (VARC-2) as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury following hemorrhage or infarction. A stroke event was based on any of the following: duration of neurological dysfunction >24 hours (h), duration of neurological dysfunction <24 h in case of imaging-documented new hemorrhage or infarction, and a neurological dysfunction resulting in death. Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability. | The composite of all-cause death, stroke (VARC-2), and major bleeding (ISTH) was assessed in the Per Protocol (PP) Analysis Set. | Posted | Count of Participants | Participants | Day 1 to Day 90 |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced Major Bleeding (International Society on Thrombosis and Hemostasis [ISTH]) in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data) | Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability. | Major bleeding was assessed in the modified Intent-to-Treat (mITT) Analysis Set. | Posted | Count of Participants | Participants | Day 1 to Day 90 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced the Composite of All-cause Death, Stroke (Alternative), and Major Bleeding (ISTH) in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data) | An alternative definition characterized stroke (ischemic, hemorrhagic, or undetermined) as an abrupt onset, over minutes to hours, of a focal neurological deficit in the distribution of a single brain artery that was not due to an identifiable nonvascular cause (ie, brain tumor or trauma), and that either lasted at least 24 hours or resulted in death within 24 hours of onset. Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability. | The composite of all-cause death, stroke (alternative), and major bleeding (ISTH) was assessed in the PP Analysis Set. | Posted | Count of Participants | Participants | Day 1 to Day 90 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced the Composite of Stroke (VARC-2), Systemic Embolic Events (SEE), and Cardiovascular (CV) Mortality in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data) | Stroke (ischemic, hemorrhagic, or undetermined) was defined by Valve Academic Research Consortium-2 (VARC-2) as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury following hemorrhage or infarction. A stroke event was based on any of the following: duration of neurological dysfunction >24 hours (h), duration of neurological dysfunction <24 h in case of imaging-documented new hemorrhage or infarction, and a neurological dysfunction resulting in death. SEE was defined as an arterial embolism resulting in clinical ischemia, excluding the central nervous system, coronary, and pulmonary arterial circulation. CV mortality was defined as cardiac or vascular death according to Academic Research Consortium. | The composite of stroke (VARC-2), systemic embolic events (SEE), and cardiovascular (CV) mortality was assessed in the PP Analysis Set. | Posted | Count of Participants | Participants | Day 1 to Day 90 |
|
Adverse event data were collected from the first dose of the study drug to 30 days after last dose of study drug.
Adverse events that emerge (or worsen) from the first dose of the study drug to the last dose of the study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Edoxaban-based Regimen | Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period. Edoxaban: Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects. | 0 | 405 | 40 | 405 | 210 | 405 |
| EG001 | VKA-based Regimen | VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen) VKA-Based Regimen: Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, UK, Taiwan and Korea. VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands. VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in France. VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Spain. | 0 | 197 | 15 | 197 | 99 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Normochromic normocytic anemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Retroperitoneal mass | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urethral obstruction | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac flutter | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Phrenic nerve paralysis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daiichi Sankyo | Contact for Clinical Trial Information | 1-908-992-6400 | CTRinfo@dsi.com |
| Aug 26, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C552171 | edoxaban |
| D014859 | Warfarin |
| D010644 | Phenprocoumon |
| C017673 | fluindione |
| D000074 | Acenocoumarol |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|
| South Korea |
|
|
| Belgium |
|
|
| Hungary |
|
|
| Czechia |
|
|
| Taiwan |
|
|
| Poland |
|
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| Italy |
|
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| United Kingdom |
|
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| Germany |
|
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| Spain |
|
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VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)
VKA-Based Regimen: Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, UK, Taiwan and Korea.
VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.
VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in France.
VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Spain.
|
|
VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)
VKA-Based Regimen: Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, UK, Taiwan and Korea.
VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.
VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in France.
VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Spain.
|
|