Atrial Fibrillation, Stroke
Conditions
Brief summary
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 three protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, 1160.136 for EU and EEA countries and 1160.171 for Switzerland. The total number of patients enrolled in three protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\) Patients newly diagnosed with non-valvular atrial fibrillation (NVAF) at risk for stroke. Further inclusion criteria apply
Exclusion criteria
1. Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention; 2. Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime; 3. AF with a generally reversible cause; 4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated. Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke (hemorrhagic and ischemic, uncertain classification) | up to 3 years | The analysis of the outcome measure is included in study 1160.129 |
| Systemic embolism | up to 3 years | The analysis of the outcome measure is included in study 1160.129 |
| Pulmonary embolism | up to 3 years | The analysis of the outcome measure is included in study 1160.129 |
| Myocardial infarction | up to 3 years | The analysis of the outcome measure is included in study 1160.129 |
| Life-threatening bleeding events | up to 3 years | The analysis of the outcome measure is included in study 1160.129 |
| All cause death | up to 3 years | The analysis of the outcome measure is included in study 1160.129 |
| Vascular death | up to 3 years | The analysis of the outcome measure is included in study 1160.129 |
| Major bleeding events (including life-threatening bleeding events) | up to 3 years | The analysis of the outcome measure is included in study 1160.129 |
| composite endpoint: Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death | up to 3 years | The analysis of the outcome measure is included in study 1160.129 |
| composite endpoint: Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint) | up to 3 years | The analysis of the outcome measure is included in study 1160.129 |
| Transient Ischemic Attack (TIA) | up to 3 years | The analysis of the outcome measure is included in study 1160.129 |
Countries
Switzerland
Outcome results
None listed