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GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)
This study is currently recruiting participants.
Verified September 2017 by Boehringer Ingelheim
Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01671007
First received: August 20, 2012
Last updated: September 18, 2017
Last verified: September 2017
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Purpose
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.
| Condition |
|---|
| Stroke Atrial Fibrillation |
| Study Type: | Observational |
| Study Design: | 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 18000 |
| Actual Study Start Date: | August 22, 2012 |
| Estimated Study Completion Date: | January 14, 2020 |
| Estimated Primary Completion Date: | January 14, 2020 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients with non-valvular AF
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671007
Show 462 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671007
Contacts
| Contact: Boehringer Ingelheim Call Center | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Show 462 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
More Information
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 |
| Study First Received: | August 20, 2012 |
| Last Updated: | September 18, 2017 |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on September 21, 2017