Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 1,164 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (SEE). Read more about this study

Who is it for?: Any age
Conditions the study is for: Atrial Fibrillation
What is being tested?: Prazaxa
How many people: 6,772 participants
Where: 1,164 sitesJapan
Study dates: 12 Dec 2011to 2 Aug 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 5000

Who may be able to join

Patients with nonvalvular atrial fibrillation who have never received Prazaxa Capsules for preventing the occurrence of ischemic stroke and systemic embolism will be included.

Who cannot join

None

Trial locations and contacts

1,164 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Japan300 sites

Boehringer Ingelheim Investigational Site 1
Abashiri, Hokkaido
Boehringer Ingelheim Investigational Site 287
Adachi,Tokyo
Boehringer Ingelheim Investigational Site 288
Adachi,Tokyo
Boehringer Ingelheim Investigational Site 289
Adachi,Tokyo
Boehringer Ingelheim Investigational Site 290
Adachi,Tokyo
Boehringer Ingelheim Investigational Site 291
Adachi,Tokyo
Boehringer Ingelheim Investigational Site 292
Adachi,Tokyo
Boehringer Ingelheim Investigational Site 1141
Aira,Kagoshima
Boehringer Ingelheim Investigational Site 622
Aisai,Aichi
Boehringer Ingelheim Investigational Site 111
Aizuwakamatsu,Fukushima
Boehringer Ingelheim Investigational Site 112
Aizuwakamatsu,Fukushima
Boehringer Ingelheim Investigational Site 815
Akashi,Hyogo
Boehringer Ingelheim Investigational Site 816
Akashi,Hyogo
Boehringer Ingelheim Investigational Site 86
Akita,Akita
Boehringer Ingelheim Investigational Site 87
Akita,Akita
Boehringer Ingelheim Investigational Site 88
Akita,Akita
Boehringer Ingelheim Investigational Site 89
Akita,Akita
Boehringer Ingelheim Investigational Site 817
Ako,Hyogo
Boehringer Ingelheim Investigational Site 818
Ako,Hyogo
Boehringer Ingelheim Investigational Site 1142
Akune,Kagoshima
Boehringer Ingelheim Investigational Site 819
Amagasaki,Hyogo
Boehringer Ingelheim Investigational Site 820
Amagasaki,Hyogo
Boehringer Ingelheim Investigational Site 821
Amagasaki,Hyogo
Boehringer Ingelheim Investigational Site 822
Amagasaki,Hyogo
Boehringer Ingelheim Investigational Site 823
Amagasaki,Hyogo
Boehringer Ingelheim Investigational Site 1084
Amakusa,Kumamoto
Boehringer Ingelheim Investigational Site 968
Anan,Tokushima
Boehringer Ingelheim Investigational Site 969
Anan,Tokushima
Boehringer Ingelheim Investigational Site 623
Anjo,Aichi
Boehringer Ingelheim Investigational Site 174
Annaka,Gunma
Boehringer Ingelheim Investigational Site 45
Aomori,Aomori
Boehringer Ingelheim Investigational Site 46
Aomori,Aomori
Boehringer Ingelheim Investigational Site 47
Aomori,Aomori
Boehringer Ingelheim Investigational Site 48
Aomori,Aomori
Boehringer Ingelheim Investigational Site 293
Arakawa,Tokyo
Boehringer Ingelheim Investigational Site 877
Arida,Wakayama
Boehringer Ingelheim Investigational Site 244
Asahi,Chiba
Boehringer Ingelheim Investigational Site 2
Asahikawa,Hokkaido
Boehringer Ingelheim Investigational Site 3
Asahikawa,Hokkaido
Boehringer Ingelheim Investigational Site 4
Asahikawa,Hokkaido
Boehringer Ingelheim Investigational Site 1013
Asakura,Fukuoka
Boehringer Ingelheim Investigational Site 157
Ashikaga,Tochigi
Boehringer Ingelheim Investigational Site 423
Asigarakami,Kanagawa
Boehringer Ingelheim Investigational Site 424
Asigarakami,Kanagawa
Boehringer Ingelheim Investigational Site 595
Atami,Shizuoka
Boehringer Ingelheim Investigational Site 552
Azumino,Nagano
Boehringer Ingelheim Investigational Site 1109
Beppu,Oita
Boehringer Ingelheim Investigational Site 903
Bizen,Okayama
Boehringer Ingelheim Investigational Site 1110
Bungotakada,Oita
Boehringer Ingelheim Investigational Site 294
Bunkyo,Tokyo
Boehringer Ingelheim Investigational Site 295
Bunkyo,Tokyo
Boehringer Ingelheim Investigational Site 296
Bunkyo,Tokyo
Boehringer Ingelheim Investigational Site 297
Bunkyo,Tokyo
Boehringer Ingelheim Investigational Site 298
Bunkyo,Tokyo
Boehringer Ingelheim Investigational Site 1014
Buzen,Fukuoka
Boehringer Ingelheim Investigational Site 245
Chiba,Chiba
Boehringer Ingelheim Investigational Site 246
Chiba,Chiba
Boehringer Ingelheim Investigational Site 247
Chiba,Chiba
Boehringer Ingelheim Investigational Site 248
Chiba,Chiba
Boehringer Ingelheim Investigational Site 249
Chiba,Chiba
Boehringer Ingelheim Investigational Site 250
Chiba,Chiba
Boehringer Ingelheim Investigational Site 251
Chiba,Chiba
Boehringer Ingelheim Investigational Site 425
Chigasaki,Kanagawa
Boehringer Ingelheim Investigational Site 426
Chigasaki,Kanagawa
Boehringer Ingelheim Investigational Site 553
Chikuma,Nagano
Boehringer Ingelheim Investigational Site 554
Chikuma,Nagano
Boehringer Ingelheim Investigational Site 127
Chikusei,Ibaraki
Boehringer Ingelheim Investigational Site 1015
Chikushino,Fukuoka
Boehringer Ingelheim Investigational Site 624
Chita,Aichi
Boehringer Ingelheim Investigational Site 299
Chiyoda,Tokyo
Boehringer Ingelheim Investigational Site 300
Chiyoda,Tokyo
Boehringer Ingelheim Investigational Site 301
Chofu,Tokyo
Boehringer Ingelheim Investigational Site 252
Choshi,Chiba
Boehringer Ingelheim Investigational Site 302
Chuo,Tokyo
Boehringer Ingelheim Investigational Site 90
Daisen,Akita
Boehringer Ingelheim Investigational Site 715
Daito,Osaka
Boehringer Ingelheim Investigational Site 716
Daito,Osaka
Boehringer Ingelheim Investigational Site 113
Date,Fukushima
Boehringer Ingelheim Investigational Site 5
Date,Hokkaido
Boehringer Ingelheim Investigational Site 6
Date,Hokkaido
Boehringer Ingelheim Investigational Site 7
Ebetsu,Hokkaido
Boehringer Ingelheim Investigational Site 8
Ebetsu,Hokkaido
Boehringer Ingelheim Investigational Site 427
Ebina,Kanagawa
Boehringer Ingelheim Investigational Site 428
Ebina,Kanagawa
Boehringer Ingelheim Investigational Site 1130
Ebino,Miyazaki
Boehringer Ingelheim Investigational Site 1131
Ebino,Miyazaki
Boehringer Ingelheim Investigational Site 531
Echizen,Fukui
Boehringer Ingelheim Investigational Site 303
Edogawa,Tokyo
Boehringer Ingelheim Investigational Site 304
Edogawa,Tokyo
Boehringer Ingelheim Investigational Site 305
Edogawa,Tokyo
Boehringer Ingelheim Investigational Site 306
Edogawa,Tokyo
Boehringer Ingelheim Investigational Site 307
Edogawa,Tokyo
Boehringer Ingelheim Investigational Site 308
Edogawa,Tokyo
Boehringer Ingelheim Investigational Site 10
Eniwa,Hokkaido
Boehringer Ingelheim Investigational Site 9
Eniwa,Hokkaido
Boehringer Ingelheim Investigational Site 309
Fuchu,Tokyo
Boehringer Ingelheim Investigational Site 310
Fuchu,Tokyo
Boehringer Ingelheim Investigational Site 311
Fuchu,Tokyo
Boehringer Ingelheim Investigational Site 312
Fuchu,Tokyo
Boehringer Ingelheim Investigational Site 537
Fuefuki,Yamanashi
Boehringer Ingelheim Investigational Site 596
Fuji,Shizuoka
Boehringer Ingelheim Investigational Site 597
Fujieda,Shizuoka
Boehringer Ingelheim Investigational Site 195
Fujimi,Saitama
Boehringer Ingelheim Investigational Site 429
Fujisawa,Kanagawa
Boehringer Ingelheim Investigational Site 430
Fujisawa,Kanagawa
Boehringer Ingelheim Investigational Site 431
Fujisawa,Kanagawa
Boehringer Ingelheim Investigational Site 432
Fujisawa,Kanagawa
Boehringer Ingelheim Investigational Site 433
Fujisawa,Kanagawa
Boehringer Ingelheim Investigational Site 538
Fujiyoshida,Yamanashi
Boehringer Ingelheim Investigational Site 539
Fujiyoshida,Yamanashi
Boehringer Ingelheim Investigational Site 196
Fukaya,Saitama
Boehringer Ingelheim Investigational Site 197
Fukaya,Saitama
Boehringer Ingelheim Investigational Site 687
Fukuchiyama,Kyoto
Boehringer Ingelheim Investigational Site 688
Fukuchiyama,Kyoto
Boehringer Ingelheim Investigational Site 532
Fukui,Fukui
Boehringer Ingelheim Investigational Site 533
Fukui,Fukui
Boehringer Ingelheim Investigational Site 534
Fukui,Fukui
Boehringer Ingelheim Investigational Site 1016
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 1017
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 1018
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 1019
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 1020
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 1021
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 1022
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 1023
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 1024
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 1025
Fukuoka,Fukuoka
Boehringer Ingelheim Investigational Site 114
Fukushima,Fukushima
Boehringer Ingelheim Investigational Site 115
Fukushima,Fukushima
Boehringer Ingelheim Investigational Site 116
Fukushima,Fukushima
Boehringer Ingelheim Investigational Site 117
Fukushima,Fukushima
Boehringer Ingelheim Investigational Site 920
Fukuyama,Hiroshima
Boehringer Ingelheim Investigational Site 921
Fukuyama,Hiroshima
Boehringer Ingelheim Investigational Site 922
Fukuyama,Hiroshima
Boehringer Ingelheim Investigational Site 923
Fukuyama,Hiroshima
Boehringer Ingelheim Investigational Site 924
Fukuyama,Hiroshima
Boehringer Ingelheim Investigational Site 253
Funabashi,Chiba
Boehringer Ingelheim Investigational Site 313
Fussa,Tokyo
Boehringer Ingelheim Investigational Site 254
Futtsu,Chiba
Boehringer Ingelheim Investigational Site 577
Fuwa,Gifu
Boehringer Ingelheim Investigational Site 625
Gamagori,Aichi
Boehringer Ingelheim Investigational Site 578
Gifu,Gifu
Boehringer Ingelheim Investigational Site 579
Gifu,Gifu
Boehringer Ingelheim Investigational Site 580
Gifu,Gifu
Boehringer Ingelheim Investigational Site 581
Gifu,Gifu
Boehringer Ingelheim Investigational Site 582
Gifu,Gifu
Boehringer Ingelheim Investigational Site 583
Gifu,Gifu
Boehringer Ingelheim Investigational Site 584
Gifu,Gifu
Boehringer Ingelheim Investigational Site 49
Goshogawara,Aomori
Boehringer Ingelheim Investigational Site 1069
Goto,Nagasaki
Boehringer Ingelheim Investigational Site 1070
Goto,Nagasaki
Boehringer Ingelheim Investigational Site 894
Gotsu,Shimane
Boehringer Ingelheim Investigational Site 198
Gyoda,Saitama
Boehringer Ingelheim Investigational Site 199
Gyoda,Saitama
Boehringer Ingelheim Investigational Site 717
Habikino,Osaka
Boehringer Ingelheim Investigational Site 718
Habikino,Osaka
Boehringer Ingelheim Investigational Site 719
Habikino,Osaka
Boehringer Ingelheim Investigational Site 50
Hachinohe,Aomori
Boehringer Ingelheim Investigational Site 314
Hachioji,Tokyo
Boehringer Ingelheim Investigational Site 315
Hachioji,Tokyo
Boehringer Ingelheim Investigational Site 316
Hachioji,Tokyo
Boehringer Ingelheim Investigational Site 317
Hachioji,Tokyo
Boehringer Ingelheim Investigational Site 318
Hachioji,Tokyo
Boehringer Ingelheim Investigational Site 319
Hachioji,Tokyo
Boehringer Ingelheim Investigational Site 434
Hadano,Kanagawa
Boehringer Ingelheim Investigational Site 948
Hagi,Yamaguchi
Boehringer Ingelheim Investigational Site 11
Hakodate,Hokkaido
Boehringer Ingelheim Investigational Site 12
Hakodate,Hokkaido
Boehringer Ingelheim Investigational Site 13
Hakodate,Hokkaido
Boehringer Ingelheim Investigational Site 519
Hakui,Ishikawa
Boehringer Ingelheim Investigational Site 520
Hakusan,Ishikawa
Boehringer Ingelheim Investigational Site 895
Hamada,Shimane
Boehringer Ingelheim Investigational Site 896
Hamada,Shimane
Boehringer Ingelheim Investigational Site 598
Hamamatsu,Shizuoka
Boehringer Ingelheim Investigational Site 599
Hamamatsu,Shizuoka
Boehringer Ingelheim Investigational Site 600
Hamamatsu,Shizuoka
Boehringer Ingelheim Investigational Site 601
Hamamatsu,Shizuoka
Boehringer Ingelheim Investigational Site 602
Hamamatsu,Shizuoka
Boehringer Ingelheim Investigational Site 603
Hamamatsu,Shizuoka
Boehringer Ingelheim Investigational Site 604
Hamamatsu,Shizuoka
Boehringer Ingelheim Investigational Site 605
Hamamatsu,Shizuoka
Boehringer Ingelheim Investigational Site 606
Hamamatsu,Shizuoka
Boehringer Ingelheim Investigational Site 607
Hamamatsu,Shizuoka
Boehringer Ingelheim Investigational Site 608
Hamamatsu,Shizuoka
Boehringer Ingelheim Investigational Site 57
Hanamaki,Iwate
Boehringer Ingelheim Investigational Site 626
Handa,Aichi
Boehringer Ingelheim Investigational Site 627
Handa,Aichi
Boehringer Ingelheim Investigational Site 628
Handa,Aichi
Boehringer Ingelheim Investigational Site 629
Handa,Aichi
Boehringer Ingelheim Investigational Site 878
Hashimoto,Wakayama
Boehringer Ingelheim Investigational Site 879
Hashimoto,Wakayama
Boehringer Ingelheim Investigational Site 1003
Hata,Kochi
Boehringer Ingelheim Investigational Site 1111
Hayami,Oita
Boehringer Ingelheim Investigational Site 200
Hidaka,Saitama
Boehringer Ingelheim Investigational Site 201
Hidaka,Saitama
Boehringer Ingelheim Investigational Site 202
Hidaka,Saitama
Boehringer Ingelheim Investigational Site 925
Higashihiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 128
Higashiibaraki,Ibaraki
Boehringer Ingelheim Investigational Site 129
Higashiibaraki,Ibaraki
Boehringer Ingelheim Investigational Site 978
Higashikagawa,Kagawa
Boehringer Ingelheim Investigational Site 320
Higashikurume, Tokyo
Boehringer Ingelheim Investigational Site 67
Higashimatsusima,Miyagi
Boehringer Ingelheim Investigational Site 68
Higashimatsusima,Miyagi
Boehringer Ingelheim Investigational Site 69
Higashimatsusima,Miyagi
Boehringer Ingelheim Investigational Site 203
Higashimatsuyama,Saitama
Boehringer Ingelheim Investigational Site 321
Higashimurayama,Tokyo
Boehringer Ingelheim Investigational Site 100
Higashine,Yamagata
Boehringer Ingelheim Investigational Site 99
Higashine,Yamagata
Boehringer Ingelheim Investigational Site 101
Higashiokitama,Yamagata
Boehringer Ingelheim Investigational Site 720
Higashiosaka,Osaka
Boehringer Ingelheim Investigational Site 721
Higashiosaka,Osaka
Boehringer Ingelheim Investigational Site 1132
Higashiusuki,Miyazaki
Boehringer Ingelheim Investigational Site 949
Hikari,Yamaguchi
Boehringer Ingelheim Investigational Site 204
Hiki,Saitama
Boehringer Ingelheim Investigational Site 679
Hikone,Shiga
Boehringer Ingelheim Investigational Site 680
Hikone,Shiga
Boehringer Ingelheim Investigational Site 824
Himeji,Hyogo
Boehringer Ingelheim Investigational Site 825
Himeji,Hyogo
Boehringer Ingelheim Investigational Site 826
Himeji,Hyogo
Boehringer Ingelheim Investigational Site 827
Himeji,Hyogo
Boehringer Ingelheim Investigational Site 828
Himeji,Hyogo
Boehringer Ingelheim Investigational Site 829
Himeji,Hyogo
Boehringer Ingelheim Investigational Site 830
Himeji,Hyogo
Boehringer Ingelheim Investigational Site 831
Himeji,Hyogo
Boehringer Ingelheim Investigational Site 832
Himeji,Hyogo
Boehringer Ingelheim Investigational Site 833
Himeji,Hyogo
Boehringer Ingelheim Investigational Site 508
Himi,Toyama
Boehringer Ingelheim Investigational Site 887
Hino,Tottori
Boehringer Ingelheim Investigational Site 722
Hirakata,Osaka
Boehringer Ingelheim Investigational Site 723
Hirakata,Osaka
Boehringer Ingelheim Investigational Site 724
Hirakata,Osaka
Boehringer Ingelheim Investigational Site 435
Hiratsuka,Kanagawa
Boehringer Ingelheim Investigational Site 14
Hiroo,Hokkaido
Boehringer Ingelheim Investigational Site 51
Hirosaki,Aomori
Boehringer Ingelheim Investigational Site 52
Hirosaki,Aomori
Boehringer Ingelheim Investigational Site 53
Hirosaki,Aomori
Boehringer Ingelheim Investigational Site 54
Hirosaki,Aomori
Boehringer Ingelheim Investigational Site 926
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 927
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 928
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 929
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 930
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 931
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 932
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 933
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 934
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 935
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 936
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 937
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 938
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 939
Hiroshima,Hiroshima
Boehringer Ingelheim Investigational Site 1112
Hita,Oita
Boehringer Ingelheim Investigational Site 130
Hitachinaka,Ibaraki
Boehringer Ingelheim Investigational Site 131
Hitachinaka,Ibaraki
Boehringer Ingelheim Investigational Site 132
Hitachiota,Ibaraki
Boehringer Ingelheim Investigational Site 950
Hofu,Yamaguchi
Boehringer Ingelheim Investigational Site 951
Hofu,Yamaguchi
Boehringer Ingelheim Investigational Site 1133
Hyuga,Miyazaki
Boehringer Ingelheim Investigational Site 725
Ibaraki,Osaka
Boehringer Ingelheim Investigational Site 726
Ibaraki,Osaka
Boehringer Ingelheim Investigational Site 727
Ibaraki,Osaka
Boehringer Ingelheim Investigational Site 585
Ibi,Gifu
Boehringer Ingelheim Investigational Site 1143
Ibusuki,Kagoshima
Boehringer Ingelheim Investigational Site 1144
Ibusuki,Kagoshima
Boehringer Ingelheim Investigational Site 1145
Ibusuki,Kagoshima
Boehringer Ingelheim Investigational Site 255
Ichihara,Chiba
Boehringer Ingelheim Investigational Site 256
Ichihara,Chiba
Boehringer Ingelheim Investigational Site 257
Ichihara,Chiba
Boehringer Ingelheim Investigational Site 258
Ichikawa,Chiba
Boehringer Ingelheim Investigational Site 259
Ichikawa,Chiba
Boehringer Ingelheim Investigational Site 1146
Ichikikushikino,Kagoshima
Boehringer Ingelheim Investigational Site 630
Ichinomiya,Aichi
Boehringer Ingelheim Investigational Site 631
Ichinomiya,Aichi
Boehringer Ingelheim Investigational Site 555
Iida,Nagano
Boehringer Ingelheim Investigational Site 556
Iida,Nagano
Boehringer Ingelheim Investigational Site 557
Iida,Nagano
Boehringer Ingelheim Investigational Site 558
Iida,Nagano
Boehringer Ingelheim Investigational Site 1026
Iizuka,Fukuoka
Boehringer Ingelheim Investigational Site 728
Ikeda,Osaka
Boehringer Ingelheim Investigational Site 729
Ikeda,Osaka
Boehringer Ingelheim Investigational Site 730
Ikeda,Osaka
Boehringer Ingelheim Investigational Site 731
Ikeda,Osaka
Boehringer Ingelheim Investigational Site 732
Ikeda,Osaka
Boehringer Ingelheim Investigational Site 870
Ikoma,Nara
Boehringer Ingelheim Investigational Site 509
Imizu,Toyama
Boehringer Ingelheim Investigational Site 559
Ina,Nagano
Boehringer Ingelheim Investigational Site 560
Ina,Nagano
Boehringer Ingelheim Investigational Site 322
Inagi,Tokyo
Boehringer Ingelheim Investigational Site 632
Inazawa,Aichi
Boehringer Ingelheim Investigational Site 633
Inuyama,Aichi
Boehringer Ingelheim Investigational Site 260
Inzai,Chiba
Boehringer Ingelheim Investigational Site 205
Iruma,Saitama
Boehringer Ingelheim Investigational Site 206
Iruma,Saitama
Boehringer Ingelheim Investigational Site 1071
Isahaya,Nagasaki
Boehringer Ingelheim Investigational Site 671
Ise,Mie
Boehringer Ingelheim Investigational Site 436
Isehara,Kanagawa
Boehringer Ingelheim Investigational Site 175
Isesaki,Gunma
Boehringer Ingelheim Investigational Site 176
Isesaki,Gunma
Boehringer Ingelheim Investigational Site 133
Ishoika,Ibaraki
Boehringer Ingelheim Investigational Site 323
Itabashi,Tokyo

Other trials in Japan

About this study

Official title: Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Patients With Nonvalvular Atrial Fibrillation

Conditions: Atrial Fibrillation
Being tested: Prazaxa
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrazaxaDrug
Dabigatran etexilate

Study groups in NCT01491178
Study group	Role	What they receive
Patients with NVAF		Not described Receives: Drug: Prazaxa

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency (Percentage) of Participants With Adverse Drug Reactions
Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as "Related", "Probably related", or "Cannot be denied".
Measured: Up to 104 weeks from first administration of study drug

Secondary outcomes (1)

Incidences of Stroke and Systemic Embolism (SEE)
Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate.
Measured: Up to 104 weeks from first administration of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 20112 Aug 2016

First posted13 Dec 2011 (estimated)
Study start12 Dec 2011
Primary completion2 Aug 2016
Study completion2 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 6,772 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01491178
Sponsor's protocol ID: 1160.130
Status last verified: Jul 2017
First submitted: 12 Dec 2011
Last updated: 30 Jan 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Koretsune Y, Kusakawa K, Harada KH, Koizumi A, Uchiyama S, Atarashi H, Okumura K, Yasaka M, Yamashita T, Taniguchi A, Fukaya T, Inoue H; for J-dabigatran surveillance and JAPAF study investigators. Characteristics of Japanese Patients with Nonvalvular Atrial Fibrillation on Anticoagulant Treatment: A Descriptive Analysis of J-dabigatran Surveillance and JAPAF Study. Cardiol Ther. 2019 Jun;8(1):43-54. doi: 10.1007/s40119-019-0129-2. Epub 2019 Feb 11.
PubMed 30746608
Inoue H, Uchiyama S, Atarashi H, Okumura K, Koretsune Y, Yasaka M, Yamashita T, Ohnishi M, Yagi N, Fukaya T; J-Dabigatran Surveillance Investigators. Post-marketing surveillance on the long-term use of dabigatran in Japanese patients with nonvalvular atrial fibrillation: Preliminary report of the J-dabigatran surveillance. J Arrhythm. 2016 Apr;32(2):145-50. doi: 10.1016/j.joa.2015.11.008. Epub 2016 Jan 16.
PubMed 27092197

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
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See locations

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Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Patients With Nonvalvular Atrial Fibrillation
ClinicalTrials.gov ID: NCT01491178
Acronym / sponsor ID: 1160.130
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 6,772 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 12 Dec 2011 (actual)
Primary completion: 2 Aug 2016 (actual)
Study completion: 2 Aug 2016 (actual)
First posted: 13 Dec 2011 (estimated)
Results: Posted 30 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with NVAF	–	Drug: Prazaxa

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 5000

Key inclusion criteria (1 listed)

Patients with nonvalvular atrial fibrillation who have never received Prazaxa Capsules for preventing the occurrence of ischemic stroke and systemic embolism will be included.

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PrazaxaDabigatran etexilate	Drug	Patients with NVAF

Primary outcome

Frequency (Percentage) of Participants With Adverse Drug Reactions
Time frame: Up to 104 weeks from first administration of study drug
Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as "Related", "Probably related", or "Cannot be denied".

1 secondary outcome

Incidences of Stroke and Systemic Embolism (SEE)
Time frame: Up to 104 weeks from first administration of study drug

Results and safety

Results posted to the registry on 30 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With NVAF	6,443	3,649

Primary outcome: Frequency (Percentage) of Participants With Adverse Drug Reactions

Time frame: Up to 104 weeks from first administration of study drug. Number. Unit: Percentage of participants

Measure	Patients With NVAF n = 6443
Value	28.2

Population analysed: Safety set: This patient set includes all patients who received treatment of Prazaxa® Capsules except those who were found not following registration rule, no actual visit, previous treatment experience with Prazaxa.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 104 weeks from first administration of study drug. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With NVAF	618 of 6,443 (9.6%)	408 of 6,443 (6.3%)	Not reported

Limitations and caveats (from the sponsor): The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30746608Koretsune Y, Kusakawa K, Harada KH, Koizumi A, Uchiyama S, Atarashi H, Okumura K, Yasaka M, Yamashita T, Taniguchi A, Fukaya T, Inoue H; for J-dabigatran surveillance and JAPAF study investigators. Characteristics of Japanese Patients with Nonvalvular Atrial Fibrillation on Anticoagulant Treatment: A Descriptive Analysis of J-dabigatran Surveillance and JAPAF Study. Cardiol Ther. 2019 Jun;8(1):43-54. doi: 10.1007/s40119-019-0129-2. Epub 2019 Feb 11.
Derived from this study: PubMed 27092197Inoue H, Uchiyama S, Atarashi H, Okumura K, Koretsune Y, Yasaka M, Yamashita T, Ohnishi M, Yagi N, Fukaya T; J-Dabigatran Surveillance Investigators. Post-marketing surveillance on the long-term use of dabigatran in Japanese patients with nonvalvular atrial fibrillation: Preliminary report of the J-dabigatran surveillance. J Arrhythm. 2016 Apr;32(2):145-50. doi: 10.1016/j.joa.2015.11.008. Epub 2016 Jan 16.
Synopsis LinkLink provided by the sponsor.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1,164 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 1,164 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,164 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency (Percentage) of Participants With Adverse Drug Reactions (time frame: Up to 104 weeks from first administration of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01491178, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.