Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 1,616 sites in Germany.

Completed

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

Trial summary

Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
How many people: 4,340 participants
Where: 1,616 sitesGermany
Study dates: Oct 2012to Jun 2013
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients

Who may be able to join

patients with atrial fibrillation foreseen for Pradaxa anticoagulation according to physician's decision for stroke prevention
patients with mild or moderate renal impairment
age >= 18 years at enrollment

Who cannot join

severe renal impairment (Creatinine Clearance < 30 ml/min)

Trial locations and contacts

1,616 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Germany300 sites

Boehringer Ingelheim Investigational Site 626
Aachen
Boehringer Ingelheim Investigational Site 627
Aachen
Boehringer Ingelheim Investigational Site 642
Aachen
Boehringer Ingelheim Investigational Site 643
Aachen
Boehringer Ingelheim Investigational Site 156
Aalen
Boehringer Ingelheim Investigational Site 159
Aalen
Boehringer Ingelheim Investigational Site 472
Aarbergen
Boehringer Ingelheim Investigational Site 830
Ahaus
Boehringer Ingelheim Investigational Site 834
Ahaus
Boehringer Ingelheim Investigational Site 853
Ahaus
Boehringer Ingelheim Investigational Site 858
Ahaus
Boehringer Ingelheim Investigational Site 842
Ahaus-Alstaette
Boehringer Ingelheim Investigational Site 1154
Ahrensburg
Boehringer Ingelheim Investigational Site 169
Aichtal
Boehringer Ingelheim Investigational Site 178
Aichtal
Boehringer Ingelheim Investigational Site 900
Albersloh
Boehringer Ingelheim Investigational Site 76
Albstadt
Boehringer Ingelheim Investigational Site 80
Albstadt
Boehringer Ingelheim Investigational Site 98
Albstadt
Boehringer Ingelheim Investigational Site 95
Albstadt-Ebingen
Boehringer Ingelheim Investigational Site 954
Alfeld
Boehringer Ingelheim Investigational Site 668
Alfter
Boehringer Ingelheim Investigational Site 211
Allersberg
Boehringer Ingelheim Investigational Site 473
Alpenrod
Boehringer Ingelheim Investigational Site 1246
Altenburg
Boehringer Ingelheim Investigational Site 1247
Altenburg
Boehringer Ingelheim Investigational Site 1268
Altenburg
Boehringer Ingelheim Investigational Site 1127
Altenholz
Boehringer Ingelheim Investigational Site 1161
Altenholz
Boehringer Ingelheim Investigational Site 543
Altenstadt
Boehringer Ingelheim Investigational Site 146
Altlußheim
Boehringer Ingelheim Investigational Site 225
Alzenau in Unterfranken
Boehringer Ingelheim Investigational Site 226
Alzenau in Unterfranken
Boehringer Ingelheim Investigational Site 228
Alzenau in Unterfranken
Boehringer Ingelheim Investigational Site 347
Amberg
Boehringer Ingelheim Investigational Site 350
Amberg
Boehringer Ingelheim Investigational Site 362
Amberg
Boehringer Ingelheim Investigational Site 1366
Anderbeck
Boehringer Ingelheim Investigational Site 1225
Apolda
Boehringer Ingelheim Investigational Site 1233
Apolda
Boehringer Ingelheim Investigational Site 1217
Arenshausen
Boehringer Ingelheim Investigational Site 818
Arnsberg
Boehringer Ingelheim Investigational Site 1222
Arnstadt
Boehringer Ingelheim Investigational Site 1224
Arnstadt
Boehringer Ingelheim Investigational Site 789
Attendorn
Boehringer Ingelheim Investigational Site 295
Attenkirchen
Boehringer Ingelheim Investigational Site 13
Au am Rhein
Boehringer Ingelheim Investigational Site 1262
Aue
Boehringer Ingelheim Investigational Site 302
Augsburg
Boehringer Ingelheim Investigational Site 303
Augsburg
Boehringer Ingelheim Investigational Site 306
Augsburg
Boehringer Ingelheim Investigational Site 315
Augsburg
Boehringer Ingelheim Investigational Site 326
Augsburg
Boehringer Ingelheim Investigational Site 327
Augsburg
Boehringer Ingelheim Investigational Site 276
Babensham
Boehringer Ingelheim Investigational Site 1074
Bad Bederkesa
Boehringer Ingelheim Investigational Site 1030
Bad Bentheim
Boehringer Ingelheim Investigational Site 478
Bad Breisig
Boehringer Ingelheim Investigational Site 1190
Bad Doberan
Boehringer Ingelheim Investigational Site 803
Bad Driburg
Boehringer Ingelheim Investigational Site 1267
Bad Elster
Boehringer Ingelheim Investigational Site 442
Bad Ems
Boehringer Ingelheim Investigational Site 443
Bad Ems
Boehringer Ingelheim Investigational Site 457
Bad Ems
Boehringer Ingelheim Investigational Site 137
Bad Friedrichshall
Boehringer Ingelheim Investigational Site 530
Bad Homburg v.d.H.
Boehringer Ingelheim Investigational Site 531
Bad Homburg v.d.H.
Boehringer Ingelheim Investigational Site 533
Bad Homburg v.d.H.
Boehringer Ingelheim Investigational Site 1250
Bad Klosterlausnitz
Boehringer Ingelheim Investigational Site 446
Bad Kreuznach
Boehringer Ingelheim Investigational Site 4
Bad Krozingen
Boehringer Ingelheim Investigational Site 1204
Bad Langensalza
Boehringer Ingelheim Investigational Site 932
Bad Lauterberg im Harz
Boehringer Ingelheim Investigational Site 934
Bad Lauterberg im Harz
Boehringer Ingelheim Investigational Site 937
Bad Lauterberg im Harz
Boehringer Ingelheim Investigational Site 680
Bad Münstereifel
Boehringer Ingelheim Investigational Site 453
Bad Nauheim
Boehringer Ingelheim Investigational Site 454
Bad Nauheim
Boehringer Ingelheim Investigational Site 528
Bad Nauheim
Boehringer Ingelheim Investigational Site 529
Bad Nauheim
Boehringer Ingelheim Investigational Site 1564
Bad Nenndorf
Boehringer Ingelheim Investigational Site 989
Bad Nenndorf
Boehringer Ingelheim Investigational Site 448
Bad Neuenahr
Boehringer Ingelheim Investigational Site 224
Bad Neustadt an der Saale
Boehringer Ingelheim Investigational Site 986
Bad Pyrmont
Boehringer Ingelheim Investigational Site 252
Bad Reichenhall
Boehringer Ingelheim Investigational Site 253
Bad Reichenhall
Boehringer Ingelheim Investigational Site 935
Bad Sachsa
Boehringer Ingelheim Investigational Site 936
Bad Sachsa
Boehringer Ingelheim Investigational Site 20
Bad Säckingen
Boehringer Ingelheim Investigational Site 874
Bad Salzuflen
Boehringer Ingelheim Investigational Site 890
Bad Salzuflen
Boehringer Ingelheim Investigational Site 1207
Bad Salzungen
Boehringer Ingelheim Investigational Site 1219
Bad Salzungen
Boehringer Ingelheim Investigational Site 87
Bad Schussenried
Boehringer Ingelheim Investigational Site 88
Bad Schussenried
Boehringer Ingelheim Investigational Site 1103
Bad Schwartau
Boehringer Ingelheim Investigational Site 1123
Bad Schwartau
Boehringer Ingelheim Investigational Site 532
Bad Soden am Taunus
Boehringer Ingelheim Investigational Site 1229
Bad Sulza
Boehringer Ingelheim Investigational Site 1582
Bad Tennstedt
Boehringer Ingelheim Investigational Site 1583
Bad Tennstedt
Boehringer Ingelheim Investigational Site 102
Bad Überkingen
Boehringer Ingelheim Investigational Site 78
Bad Waldsee
Boehringer Ingelheim Investigational Site 259
Bad Wiesee
Boehringer Ingelheim Investigational Site 235
Bad Wiessee
Boehringer Ingelheim Investigational Site 42
Bad Wildbad
Boehringer Ingelheim Investigational Site 68
Bad Wildbad
Boehringer Ingelheim Investigational Site 1375
Badel
Boehringer Ingelheim Investigational Site 3
Baden-Baden
Boehringer Ingelheim Investigational Site 961
Badenhausen
Boehringer Ingelheim Investigational Site 83
Baindt
Boehringer Ingelheim Investigational Site 84
Baindt
Boehringer Ingelheim Investigational Site 1488
Bamberg
Boehringer Ingelheim Investigational Site 1494
Bamberg
Boehringer Ingelheim Investigational Site 1592
Bamberg
Boehringer Ingelheim Investigational Site 1232
Barchfeld
Boehringer Ingelheim Investigational Site 1153
Bargteheide
Boehringer Ingelheim Investigational Site 1026
Barssel/Harkebruegge
Boehringer Ingelheim Investigational Site 1514
Barssel/Harkebruegge
Boehringer Ingelheim Investigational Site 1434
Baruth
Boehringer Ingelheim Investigational Site 1587
Bassum
Boehringer Ingelheim Investigational Site 971
Bassum
Boehringer Ingelheim Investigational Site 445
Baumholder
Boehringer Ingelheim Investigational Site 450
Baumholder
Boehringer Ingelheim Investigational Site 570
Baunatal
Boehringer Ingelheim Investigational Site 1437
Bautzen
Boehringer Ingelheim Investigational Site 1597
Bayreuth
Boehringer Ingelheim Investigational Site 378
Bayreuth
Boehringer Ingelheim Investigational Site 415
Bechhofen
Boehringer Ingelheim Investigational Site 883
Beckum
Boehringer Ingelheim Investigational Site 884
Beckum
Boehringer Ingelheim Investigational Site 1460
Beilrode
Boehringer Ingelheim Investigational Site 219
Bellngries
Boehringer Ingelheim Investigational Site 466
Bendorf
Boehringer Ingelheim Investigational Site 489
Bensheim
Boehringer Ingelheim Investigational Site 517
Bensheim
Boehringer Ingelheim Investigational Site 908
Berg. Gladbach
Boehringer Ingelheim Investigational Site 1195
Bergen
Boehringer Ingelheim Investigational Site 814
Bergkamen-Ruenthe
Boehringer Ingelheim Investigational Site 1143
Berlin
Boehringer Ingelheim Investigational Site 1270
Berlin
Boehringer Ingelheim Investigational Site 1271
Berlin
Boehringer Ingelheim Investigational Site 1277
Berlin
Boehringer Ingelheim Investigational Site 1278
Berlin
Boehringer Ingelheim Investigational Site 1279
Berlin
Boehringer Ingelheim Investigational Site 1280
Berlin
Boehringer Ingelheim Investigational Site 1281
Berlin
Boehringer Ingelheim Investigational Site 1282
Berlin
Boehringer Ingelheim Investigational Site 1285
Berlin
Boehringer Ingelheim Investigational Site 1304
Berlin
Boehringer Ingelheim Investigational Site 1305
Berlin
Boehringer Ingelheim Investigational Site 1306
Berlin
Boehringer Ingelheim Investigational Site 1307
Berlin
Boehringer Ingelheim Investigational Site 1309
Berlin
Boehringer Ingelheim Investigational Site 1310
Berlin
Boehringer Ingelheim Investigational Site 1311
Berlin
Boehringer Ingelheim Investigational Site 1312
Berlin
Boehringer Ingelheim Investigational Site 1315
Berlin
Boehringer Ingelheim Investigational Site 1316
Berlin
Boehringer Ingelheim Investigational Site 1318
Berlin
Boehringer Ingelheim Investigational Site 1319
Berlin
Boehringer Ingelheim Investigational Site 1320
Berlin
Boehringer Ingelheim Investigational Site 1321
Berlin
Boehringer Ingelheim Investigational Site 1322
Berlin
Boehringer Ingelheim Investigational Site 1323
Berlin
Boehringer Ingelheim Investigational Site 1325
Berlin
Boehringer Ingelheim Investigational Site 1326
Berlin
Boehringer Ingelheim Investigational Site 1328
Berlin
Boehringer Ingelheim Investigational Site 1329
Berlin
Boehringer Ingelheim Investigational Site 1330
Berlin
Boehringer Ingelheim Investigational Site 1331
Berlin
Boehringer Ingelheim Investigational Site 1336
Berlin
Boehringer Ingelheim Investigational Site 1338
Berlin
Boehringer Ingelheim Investigational Site 1377
Berlin
Boehringer Ingelheim Investigational Site 1382
Berlin
Boehringer Ingelheim Investigational Site 1384
Berlin
Boehringer Ingelheim Investigational Site 1385
Berlin
Boehringer Ingelheim Investigational Site 1386
Berlin
Boehringer Ingelheim Investigational Site 1387
Berlin
Boehringer Ingelheim Investigational Site 1388
Berlin
Boehringer Ingelheim Investigational Site 1389
Berlin
Boehringer Ingelheim Investigational Site 1390
Berlin
Boehringer Ingelheim Investigational Site 1406
Berlin
Boehringer Ingelheim Investigational Site 1407
Berlin
Boehringer Ingelheim Investigational Site 1408
Berlin
Boehringer Ingelheim Investigational Site 1540
Berlin
Boehringer Ingelheim Investigational Site 1541
Berlin
Boehringer Ingelheim Investigational Site 1542
Berlin
Boehringer Ingelheim Investigational Site 1543
Berlin
Boehringer Ingelheim Investigational Site 1544
Berlin
Boehringer Ingelheim Investigational Site 1545
Berlin
Boehringer Ingelheim Investigational Site 1546
Berlin
Boehringer Ingelheim Investigational Site 1547
Berlin
Boehringer Ingelheim Investigational Site 1549
Berlin
Boehringer Ingelheim Investigational Site 393
Berlin
Boehringer Ingelheim Investigational Site 1308
Bernau
Boehringer Ingelheim Investigational Site 1550
Bernau
Boehringer Ingelheim Investigational Site 1433
Bernsdorf
Boehringer Ingelheim Investigational Site 460
Beselich-Obertiefenbach
Boehringer Ingelheim Investigational Site 474
Beselich-Obertiefenbach
Boehringer Ingelheim Investigational Site 611
Bettingen
Boehringer Ingelheim Investigational Site 823
Beverungen
Boehringer Ingelheim Investigational Site 77
Biberach
Boehringer Ingelheim Investigational Site 512
Biblis
Boehringer Ingelheim Investigational Site 563
Biedenkopf
Boehringer Ingelheim Investigational Site 584
Biedenkopf
Boehringer Ingelheim Investigational Site 876
Bielefeld
Boehringer Ingelheim Investigational Site 901
Bielefeld
Boehringer Ingelheim Investigational Site 94
Bingen
Boehringer Ingelheim Investigational Site 1215
Bischofferode
Boehringer Ingelheim Investigational Site 504
Bischofsheim
Boehringer Ingelheim Investigational Site 1376
Bismark
Boehringer Ingelheim Investigational Site 1085
Bispingen
Boehringer Ingelheim Investigational Site 1370
Bitterfeld-Wolfen
Boehringer Ingelheim Investigational Site 1371
Bitterfeld-Wolfen
Boehringer Ingelheim Investigational Site 92
Blaubeuren Abbey
Boehringer Ingelheim Investigational Site 1580
Bleicherode
Boehringer Ingelheim Investigational Site 896
Blomberg
Boehringer Ingelheim Investigational Site 57
Blumberg
Boehringer Ingelheim Investigational Site 1572
Böblingen
Boehringer Ingelheim Investigational Site 48
Böblingen
Boehringer Ingelheim Investigational Site 51
Böblingen
Boehringer Ingelheim Investigational Site 1420
Bobritzsch
Boehringer Ingelheim Investigational Site 769
Bochum
Boehringer Ingelheim Investigational Site 771
Bochum
Boehringer Ingelheim Investigational Site 773
Bochum
Boehringer Ingelheim Investigational Site 775
Bochum
Boehringer Ingelheim Investigational Site 777
Bochum
Boehringer Ingelheim Investigational Site 778
Bochum
Boehringer Ingelheim Investigational Site 779
Bochum
Boehringer Ingelheim Investigational Site 780
Bochum
Boehringer Ingelheim Investigational Site 339
Bodenkirchen
Boehringer Ingelheim Investigational Site 1457
Böhlen
Boehringer Ingelheim Investigational Site 682
Bonn
Boehringer Ingelheim Investigational Site 41
Bonndorf
Boehringer Ingelheim Investigational Site 55
Bonndorf
Boehringer Ingelheim Investigational Site 1137
Boostedt
Boehringer Ingelheim Investigational Site 158
Bopfingen
Boehringer Ingelheim Investigational Site 1162
Bordesholm
Boehringer Ingelheim Investigational Site 899
Borgholzhausen
Boehringer Ingelheim Investigational Site 844
Borken
Boehringer Ingelheim Investigational Site 1476
Borna
Boehringer Ingelheim Investigational Site 838
Bottrop
Boehringer Ingelheim Investigational Site 852
Bottrop
Boehringer Ingelheim Investigational Site 962
Bovenden-Reyershausen
Boehringer Ingelheim Investigational Site 1010
Brake
Boehringer Ingelheim Investigational Site 1023
Brake
Boehringer Ingelheim Investigational Site 1038
Bramsche
Boehringer Ingelheim Investigational Site 54
Bräunlingen
Boehringer Ingelheim Investigational Site 1456
Braunsbedra
Boehringer Ingelheim Investigational Site 940
Braunschweig
Boehringer Ingelheim Investigational Site 941
Braunschweig
Boehringer Ingelheim Investigational Site 943
Braunschweig
Boehringer Ingelheim Investigational Site 949
Braunschweig
Boehringer Ingelheim Investigational Site 1496
Breitenguessbach
Boehringer Ingelheim Investigational Site 1053
Bremen
Boehringer Ingelheim Investigational Site 1061
Bremen
Boehringer Ingelheim Investigational Site 1062
Bremen
Boehringer Ingelheim Investigational Site 1063
Bremen
Boehringer Ingelheim Investigational Site 1064
Bremen
Boehringer Ingelheim Investigational Site 1065
Bremen
Boehringer Ingelheim Investigational Site 1066
Bremen
Boehringer Ingelheim Investigational Site 1067
Bremen
Boehringer Ingelheim Investigational Site 1068
Bremen
Boehringer Ingelheim Investigational Site 1069
Bremen
Boehringer Ingelheim Investigational Site 1045
Bremerhaven
Boehringer Ingelheim Investigational Site 1046
Bremerhaven
Boehringer Ingelheim Investigational Site 1048
Bremerhaven
Boehringer Ingelheim Investigational Site 1079
Bremerhaven
Boehringer Ingelheim Investigational Site 1050
Bremervörde
Boehringer Ingelheim Investigational Site 143
Bretten
Boehringer Ingelheim Investigational Site 1611
Bretten
Boehringer Ingelheim Investigational Site 806
Brilon
Boehringer Ingelheim Investigational Site 431
Bruchweiler-Baerenbach
Boehringer Ingelheim Investigational Site 363
Bruck
Boehringer Ingelheim Investigational Site 337
Buchbach
Boehringer Ingelheim Investigational Site 338
Buchbach
Boehringer Ingelheim Investigational Site 1145
Büchen
Boehringer Ingelheim Investigational Site 1146
Büchen
Boehringer Ingelheim Investigational Site 1500
Büchen
Boehringer Ingelheim Investigational Site 1519
Büchen
Boehringer Ingelheim Investigational Site 1051
Buchholz
Boehringer Ingelheim Investigational Site 1083
Buchholz
Boehringer Ingelheim Investigational Site 968
Bückeburg
Boehringer Ingelheim Investigational Site 1335
Buckow
Boehringer Ingelheim Investigational Site 878
Bünde
Boehringer Ingelheim Investigational Site 828
Büren
Boehringer Ingelheim Investigational Site 1294
Burg
Boehringer Ingelheim Investigational Site 980
Burgdorf, Hanover
Boehringer Ingelheim Investigational Site 985
Burgdorf, Hanover
Boehringer Ingelheim Investigational Site 1432
Burgneudorf
Boehringer Ingelheim Investigational Site 557
Butzbach
Boehringer Ingelheim Investigational Site 800
Castrop-Rauxel
Boehringer Ingelheim Investigational Site 810
Castrop-Rauxel
Boehringer Ingelheim Investigational Site 812
Castrop-Rauxel
Boehringer Ingelheim Investigational Site 824
Castrop-Rauxel
Boehringer Ingelheim Investigational Site 1239
Chemnitz
Boehringer Ingelheim Investigational Site 1240
Chemnitz
Boehringer Ingelheim Investigational Site 1241
Chemnitz

Other trials in Germany

About this study

Official title: Use of Pradaxa® (Dabigatran Etexilate) for Stroke Prevention in Patients With Nonvalvular Atrial Fibrillation and Mild to Moderate Renal Impairment

Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment

Conditions: Atrial Fibrillation
Medical subject headings: Atrial Fibrillation

What participants receive

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

Study groups in NCT01721837
Study group	Role	What they receive
Atrial fibrillation and mild to moderate renal impairment		Not described

What is being measured

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

Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)
The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.
Measured: One single observation time point: at the time of prescription before the first intake of dabigatran etexilate

Timeline

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

Oct 2012Jun 2013

First posted6 Nov 2012 (estimated)
Study startOct 2012
Primary completionJun 2013
Study completionJun 2013

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.
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: Cohort
Time perspective: Prospective
Enrolment: 4,340 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01721837
Sponsor's protocol ID: 1160.170
Status last verified: Jun 2014
First submitted: 2 Nov 2012
Last updated: 31 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

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?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Pradaxa® (Dabigatran Etexilate) for Stroke Prevention in Patients With Nonvalvular Atrial Fibrillation and Mild to Moderate Renal Impairment
ClinicalTrials.gov ID: NCT01721837
Acronym / sponsor ID: 1160.170
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 4,340 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 6 Nov 2012 (estimated)
Results: Posted 31 Jul 2014

Clinical summary

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

Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Atrial fibrillation and mild to moderate renal impairment	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients

Key inclusion criteria (3 listed)

patients with atrial fibrillation foreseen for Pradaxa anticoagulation according to physician's decision for stroke prevention
patients with mild or moderate renal impairment
age >= 18 years at enrollment

Key exclusion criteria (1 listed)

severe renal impairment (Creatinine Clearance < 30 ml/min)

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

Primary outcome

Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)
Time frame: One single observation time point: at the time of prescription before the first intake of dabigatran etexilate
The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.

Results and safety

Results posted to the registry on 31 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients	2,120	2,120

Primary outcome: Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)

Time frame: One single observation time point: at the time of prescription before the first intake of dabigatran etexilate. Median (Inter-Quartile Range). Unit: ml/min

Measure	All Patients n = 1975
Value	55.2 (43.6 to 68.3)

Population analysed: All patients with documented mild or moderate renal impairment and non-valvular atrial fibrillation (PPS) having evaluable data for age, gender, body weight, and serum creatinine. In 145 patients age, gender, serum creatinine or weight was missing so that Creatinine Clearance according to the Cockcroft Gault formula could not be recalculated.

Adverse events

Time frame: One single observation time point: at the time of prescription before the first intake of dabigatran etexilate. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): This non-interventional studies is conducted according to §67, section 6 German Medicines Act. The term 'principal investigator' is not applicable.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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

1,616 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 1,616 sites in Germany.

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 3 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 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,616 sites in Germany. 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 31 Jul 2014). 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?

Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician) (time frame: One single observation time point: at the time of prescription before the first intake of dabigatran etexilate). 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 NCT01721837.

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 31 Jul 2014.