18 and older, any sex, with Stroke or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase IIPrimary· From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Group
Value
95% CI
Dabigatran Etexilate - Baseline (Phase II)
2.06
1.74 – 2.42
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase IIIPrimary· From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incid
Group
Value
95% CI
Dabigatran Etexilate - Baseline (Phase III)
2.21
1.88 – 2.57
Vitamin K Antagonist (VKA) - Baseline (Phase III)
3.23
2.83 – 3.62
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase IIPrimary· From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Group
Value
95% CI
Dabigatran Etexilate - Baseline (Phase II)
1.74
1.45 – 2.07
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase IIIPrimary· From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bo
Group
Value
95% CI
Dabigatran Etexilate - Baseline (Phase III)
1.91
1.59 – 2.24
Vitamin K Antagonist (VKA) - Baseline (Phase III)
2.62
2.27 – 2.96
Incidence Rate of Stroke or Systemic Embolism - Phase IIIPrimary· From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Group
Value
95% CI
Dabigatran Etexilate - Baseline (Phase III)
0.80
0.61 – 1.01
Vitamin K Antagonist (VKA) - Baseline (Phase III)
1.00
0.80 – 1.22
Incidence Rate of Stroke - Phase IIPrimary· From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Group
Value
95% CI
Dabigatran Etexilate - Baseline (Phase II)
0.65
0.48 – 0.87
Incidence Rate of Stroke - Phase IIIPrimary· From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Group
Value
95% CI
Dabigatran Etexilate - Baseline (Phase III)
0.77
0.58 – 0.97
Vitamin K Antagonist (VKA) - Baseline (Phase III)
0.96
0.76 – 1.17
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase IIPrimary· From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Group
Value
95% CI
Dabigatran Etexilate - Baseline (Phase II)
0.21
0.12 – 0.34
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase IIIPrimary· From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Group
Value
95% CI
Dabigatran Etexilate - Baseline (Phase III)
0.29
0.17 – 0.42
Vitamin K Antagonist (VKA) - Baseline (Phase III)
0.32
0.21 – 0.45
Incidence Rate of Systemic Embolism (SE) - Phase IIPrimary· From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Group
Value
95% CI
Dabigatran Etexilate - Baseline (Phase II)
0.04
0.01 – 0.12
Incidence Rate of Systemic Embolism (SE) - Phase IIIPrimary· From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Group
Value
95% CI
Dabigatran Etexilate - Baseline (Phase III)
0.04
0.00 – 0.09
Vitamin K Antagonist (VKA) - Baseline (Phase III)
0.05
0.01 – 0.09
Incidence Rate of Pulmonary Embolism (PE) - Phase IIPrimary· From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Group
Value
95% CI
Dabigatran Etexilate - Baseline (Phase II)
0.07
0.02 – 0.16
Adverse events — posted to ClinicalTrials.gov
Time frame: Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dabigatran Etexilate - Baseline (Phase II)
Serious: 985/4943 (20%)
Deaths: 184/4943
Dabigatran Etexilate - at Least Once During Phase III of the Study
Serious: 118/4477 (3%)
Deaths: 199/4477
Vitamin K Antagonist (VKA) - at Least Once During Phase III of the Study
Serious: 296/5894 (5%)
Deaths: 465/5894
Rivaroxaban - at Least Once During Phase III of the Study
Serious: 185/5177 (4%)
Deaths: 292/5177
Apixaban - at Least Once During Phase III of the Study
Serious: 217/6024 (4%)
Deaths: 392/6024
Edoxaban - at Least Once During Phase III of the Study
Serious: 16/686 (2%)
Deaths: 23/686
Acetylsalicylic Acid (ASA) - at Least Once During Phase III of the Study
Serious: 225/6263 (4%)
Deaths: 469/6263
Antiplts Other Than ASA - at Least Once During Phase III of the Study
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06615973 — Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke
· recruiting
NCT07494890 — Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment
· NA
· recruiting
NCT07356011 — Exoskeleton for Balance
· NA
· recruiting
NCT07523503 — Unilateral Versus Bilateral Task-specific Training on Motor Impairment, Upper Extremity Function, and Hand Dexterity in
· NA
· recruiting
NCT06704074 — Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 29 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01468701.