GLORIA-AF Registry Program - Second and Third Phases

Study ID
1160.129

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Clements University Hospital

Contact


Principal Investigator

Official Title

GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)

Brief Overview


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.

Participant Eligibility


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