GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease
Stroke; Atrial Fibrillation

Study Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ]
2. Transient ischemic attack (TIA) [ Time Frame: up to 3 years ]
3. All cause death [ Time Frame: up to 3 years ]
4. Life-threatening bleeding events [ Time Frame: up to 3 years ]
5. Major bleeding events (including life-threatening bleeding events) [ Time Frame: up to 3 years ]
6. Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ]
7. Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint) [ Time Frame: up to 3 years ]
8. Vascular death [ Time Frame: up to 3 years ]
9. Systemic embolism [ Time Frame: up to 3 years ]
10. Pulmonary embolism [ Time Frame: up to 3 years ]
11. Myocardial infarction [ Time Frame: up to 3 years ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 527 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Huisman MV, Lip GY, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Teutsch C, Zint K, Ackermann D, Clemens A, Bartels DB. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014 Mar;167(3):329-34. doi: 10.1016/j.ahj.2013.12.006. Epub 2013 Dec 19.

Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01671007 History of Changes
Other Study ID Numbers:	1160.136
First Posted:	August 23, 2012
Last Update Posted:	March 29, 2018
Last Verified:	March 2018

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes