GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)
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ClinicalTrials.gov Identifier: NCT01671007 |
Recruitment Status
:
Active, not recruiting
First Posted
: August 23, 2012
Last Update Posted
: March 29, 2018
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Condition or disease |
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Stroke Atrial Fibrillation |
Study Type : | Observational |
Estimated Enrollment : | 18000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase II/III - EU/EEA Member States) |
Actual Study Start Date : | August 22, 2012 |
Estimated Primary Completion Date : | January 14, 2020 |
Estimated Study Completion Date : | January 14, 2020 |

- Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ]
- Transient ischemic attack (TIA) [ Time Frame: up to 3 years ]
- All cause death [ Time Frame: up to 3 years ]
- Life-threatening bleeding events [ Time Frame: up to 3 years ]
- Major bleeding events (including life-threatening bleeding events) [ Time Frame: up to 3 years ]
- Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ]
- Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint) [ Time Frame: up to 3 years ]
- Vascular death [ Time Frame: up to 3 years ]
- Systemic embolism [ Time Frame: up to 3 years ]
- Pulmonary embolism [ Time Frame: up to 3 years ]
- Myocardial infarction [ Time Frame: up to 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion criteria:
- Age =>18 years at enrollment
- Male or female patient (or legally acceptable representative) willing and able to provide written informed consent
- Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke.
Other inclusion criteria apply.
Exclusion criteria:
- Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
- Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
- AF with a generally reversible cause;
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671007

Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01671007 History of Changes |
Other Study ID Numbers: |
1160.136 |
First Posted: | August 23, 2012 Key Record Dates |
Last Update Posted: | March 29, 2018 |
Last Verified: | March 2018 |
Additional relevant MeSH terms:
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |