GLORIA-AF Registry Program (Phase II/III)

Active, not recruiting

Phase N/A Results N/A

Update History

30 Aug '17
The Summary of Purpose was updated.
New
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 India and 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.
Old
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 India and 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.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
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 exclusion criteria apply
Old
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 exclusion criteria apply
27 Apr '16
A location was updated in Basel.
New
The overall status was removed for 1160.171.44001 Boehringer Ingelheim Investigational Site.
A location was updated in Lausanne.
New
The overall status was removed for 1160.171.44008 Boehringer Ingelheim Investigational Site.
A location was updated in Lugano.
New
The overall status was removed for 1160.171.44002 Boehringer Ingelheim Investigational Site.
A location was updated in St. Gallen.
New
The overall status was removed for 1160.171.44004 Boehringer Ingelheim Investigational Site.
A location was updated in Urtenen-Schonbuhl.
New
The overall status was removed for 1160.171.44005 Boehringer Ingelheim Investigational Site.
10 Mar '16
The eligibility criteria were updated.
New
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 exclusion criteria apply
Old
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.
25 Jul '14
A location was updated in Lausanne.
New
The overall status was removed for 1160.171.44008 Boehringer Ingelheim Investigational Site.
21 Feb '14
A location was updated in Lugano.
New
The overall status was removed for 1160.171.44002 Boehringer Ingelheim Investigational Site.
A location was updated in St. Gallen.
New
The overall status was removed for 1160.171.44004 Boehringer Ingelheim Investigational Site.
7 Feb '14
A location was updated in Basel.
New
The overall status was updated to "Recruiting" at 1160.171.44006 Boehringer Ingelheim Investigational Site.
A location was updated in Urtenen-Schonbuhl.
New
The overall status was removed for 1160.171.44005 Boehringer Ingelheim Investigational Site.