GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)

• CHADS2 Score [cardiac failure, hypertension, age, diabetes, stroke (doubled)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
• CHA2DS2VASc Score [cardiac failure, hypertension, age >=75 (doubled), diabetes, stroke (doubled), vascular disease, age 65-74 and sex category (female)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
• HAS-BLED score [hypertension, abnormal renal/liver function (1 point each), stroke, bleeding history or predisposition, labile international Normalized Ratio (INR), elderly (>65), drugs/alcohol concomitantly (1 point each)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
• Antithrombotic treatment choice at baseline [ Time Frame: 1 day ] [ Designated as safety issue: No ]
• Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
• Transient ischemic attack (TIA) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
• systemic embolism [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
• pulmonary embolism [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
• myocardial infarction [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
• life-threatening bleeding events [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
• Major bleeding events [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
• All cause death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
• Non-vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
• Death of unknown cause [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
• vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
• composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

• Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators outside the Summary of Product Characteristics (SmPC) indication. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
• Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators with contraindications (overall and per contraindication captured) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
• Phase II only: Percentage and characterization of dabigatran initiators with relevant comedications that should be used with caution [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
• Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators without assessment of renal function (no serum creatinine reported) prior treatment initiation. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
• Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators receiving 110 mg BID (twice daily) although 150 mg BID is recommended according to SmPC [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
• Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators receiving 150 mg BID although 110 mg BID is recommended according to SmPC (e.g. patients > 80 years or patients with high bleeding risk) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
• Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators without an interruption of dabigatran due to outcome events (e.g. major bleeds, major trauma), procedures. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]

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.

patients with non-valvular AF

• Stroke
• Atrial Fibrillation

Inclusion criteria:

1) Patients newly diagnosed with non-valvular atrial fibrillation (NVAF) at risk for stroke.

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