GLORIA-AF Registry Program - Second and Third Phases

Boehringer Ingelheim

Status: Completed

Conditions: Atrial Fibrillation; Stroke

Study type: Observational

Funder types: Industry

Identifiers

NCT01468701

1160.129

Details and patient eligibility

About

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.

Enrollment: 37,235 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age =>18 years at enrollment
2. Male or female patient (or legally acceptable representative) willing and able to provide written informed consent
3. Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke.

Other 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 Other exclusion criteria apply

Trial design