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)Primary· From baseline visit 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) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. 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 bootstrapping approach was used to obtain the 95% confidence in
Group
Value
95% CI
Dabigatran Etexilate - Baseline
2.30
1.86 – 2.73
Vitamin K Antagonist (VKA) - Baseline
3.02
2.54 – 3.54
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death)Primary· From baseline visit 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) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. 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 bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Group
Value
95% CI
Dabigatran Etexilate - Baseline
1.91
1.52 – 2.32
Vitamin K Antagonist (VKA) - Baseline
2.36
1.93 – 2.82
Incidence Rate of Stroke or Systemic EmbolismPrimary· From baseline visit 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) and Vitamin K Antagonist (VKA) only.
Group
Value
95% CI
Dabigatran Etexilate - Baseline
0.69
0.45 – 0.94
Vitamin K Antagonist (VKA) - Baseline
1.01
0.76 – 1.30
Incidence Rate of StrokePrimary· From baseline visit 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) and Vitamin K Antagonist (VKA) 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
0.64
0.42 – 0.89
Vitamin K Antagonist (VKA) - Baseline
0.96
0.70 – 1.22
Incidence Rate of Transient Ischaemic Attack (TIA)Primary· From baseline visit 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) and Vitamin K Antagonist (VKA) only.
Group
Value
95% CI
Dabigatran Etexilate - Baseline
0.30
0.16 – 0.47
Vitamin K Antagonist (VKA) - Baseline
0.26
0.12 – 0.41
Incidence Rate of Systemic Embolism (SEE)Primary· From baseline visit 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 (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Group
Value
95% CI
Dabigatran Etexilate - Baseline
0.07
0.00 – 0.16
Vitamin K Antagonist (VKA) - Baseline
0.06
0.00 – 0.14
Incidence Rate of Pulmonary Embolism (PE)Primary· From baseline visit 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 pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Group
Value
95% CI
Dabigatran Etexilate - Baseline
0.09
0.02 – 0.18
Vitamin K Antagonist (VKA) - Baseline
0.06
0.00 – 0.14
Incidence Rate of Major Bleeding EventsPrimary· From baseline visit 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 major bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening
Group
Value
95% CI
Dabigatran Etexilate - Baseline
0.73
0.49 – 0.98
Vitamin K Antagonist (VKA) - Baseline
1.42
1.09 – 1.75
Incidence Rate of Life-threatening Bleeding EventsPrimary· From baseline visit 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 life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Group
Value
95% CI
Dabigatran Etexilate - Baseline
0.50
0.31 – 0.71
Vitamin K Antagonist (VKA) - Baseline
1.04
0.77 – 1.34
Incidence Rate of Vascular DeathPrimary· From baseline visit 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 death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Group
Value
95% CI
Dabigatran Etexilate - Baseline
0.76
0.51 – 1.02
Vitamin K Antagonist (VKA) - Baseline
1.00
0.73 – 1.29
Incidence Rate of Myocardial InfarctionPrimary· From baseline visit 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 myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Group
Value
95% CI
Dabigatran Etexilate - Baseline
0.34
0.18 – 0.53
Vitamin K Antagonist (VKA) - Baseline
0.45
0.27 – 0.64
Incidence Rate of All-cause DeathPrimary· From baseline visit 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 all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Group
Value
95% CI
Dabigatran Etexilate - Baseline
2.08
1.69 – 2.51
Vitamin K Antagonist (VKA) - Baseline
3.27
2.80 – 3.77
Adverse events — posted to ClinicalTrials.gov
Time frame: From baseline visit until study completion or discontinuation, up to 3 years of follow-up..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dabigatran Etexilate - at Least Once During the Study
Serious: 79/2385 (3%)
Deaths: 116/2385
Vitamin K Antagonist (VKA) - at Least Once During the Study
Serious: 157/3258 (5%)
Deaths: 264/3258
Rivaroxaban - at Least Once During the Study
Serious: 92/2576 (4%)
Deaths: 166/2576
Apixaban - at Least Once During the Study
Serious: 99/2934 (3%)
Deaths: 207/2934
Edoxaban - at Least Once During the Study
Serious: 10/368 (3%)
Deaths: 17/368
Acetylsalicylic Acid (ASA) - at Least Once During the Study
Serious: 70/1940 (4%)
Deaths: 141/1940
Antiplts Other Than ASA - at Least Once During 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 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: 31 December 2020
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/NCT01671007.