GLORIA-AF Registry Program - Second and Third Phases

Tracking Information
First Submitted Date	October 28, 2011
First Posted Date	November 9, 2011
Last Update Posted Date	March 29, 2018
Actual Study Start Date	November 7, 2011
Estimated Primary Completion Date	January 14, 2020 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: January 26, 2016)	Myocardial infarction [ Time Frame: up to 3 years ]; Life-threatening bleeding events [ Time Frame: up to 3 years ]; All cause death [ Time Frame: up to 3 years ]; Vascular death [ Time Frame: up to 3 years ]; composite endpoint: Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint) [ Time Frame: up to 3 years ]; Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ]; Transient Ischemic attack (TIA) [ Time Frame: up to 3 years ]; Systemic embolism [ Time Frame: up to 3 years ]; Pulmonary embolism [ Time Frame: up to 3 years ]; composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ]; Major bleeding events (including life-threatening bleeding events) [ Time Frame: up to 3 years ]
Original Primary Outcome Measures; (submitted: November 7, 2011)	Myocardial infarction [ Time Frame: up to 3 years ]; Life-threatening bleeding events [ Time Frame: up to 3 years ]; Major bleeding events [ Time Frame: up to 3 years ]; All cause death [ Time Frame: up to 3 years ]; Non-vascular death [ Time Frame: up to 3 years ]; Death of unknown cause [ Time Frame: up to 3 years ]; vascular death [ Time Frame: up to 3 years ]; Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ]; Age Group [ Time Frame: 1 day ]; Gender [ Time Frame: 1 day ]; CHADS2 Score [cardiac failure, hypertension, age, diabetes, stroke (doubled)] [ Time Frame: 1 day ]; CHA2DS2-VASc Score [cardiac failure, hypertension, age >=75 (doubled), diabetes, stroke (doubled), vascular disease, age 65-74 and sex category (female) [ Time Frame: 1 day ]; HAS-BLED score [hypertension, abnormal renal/liver function (1 point each), stroke, bleeding history or predisposition, labile International Normalized Ratio (INR), elderly (>65), drugs/alcohol concomitantly (1 point each)] [ Time Frame: 1 day ]; Antithrombotic treatment choice at baseline [ Time Frame: 1 day ]; Transient Ischemic attack (TIA) [ Time Frame: up to 3 years ]; Systemic embolism [ Time Frame: up to 3 years ]; Pulmonary embolism [ Time Frame: up to 3 years ]; composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ]
Change History	Complete list of historical versions of study NCT01468701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	GLORIA-AF Registry Program - Second and Third Phases
Official Title	GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)
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 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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	patients with non-valvular AF
Condition	Stroke; Atrial Fibrillation
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Zint K, Elsaesser A, Bartels DB, Lip GY; GLORIA-AF Investigators. The Changing Landscape for Stroke Prevention in AF: Findings From the GLORIA-AF Registry Phase 2. J Am Coll Cardiol. 2017 Feb 21;69(7):777-785. doi: 10.1016/j.jacc.2016.11.061.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Active, not recruiting
Estimated Enrollment; (submitted: September 19, 2016)	19000
Original Estimated Enrollment; (submitted: November 7, 2011)	30000
Estimated Study Completion Date	January 14, 2020
Estimated Primary Completion Date	January 14, 2020 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, Hong Kong, Japan, Korea, Republic of, Lebanon, Mexico, Peru, Russian Federation, Saudi Arabia, Singapore, South Africa, Taiwan, United Arab Emirates, United States, Venezuela
Removed Location Countries	Croatia, Puerto Rico, Turkey
Administrative Information
NCT Number	NCT01468701
Other Study ID Numbers	1160.129
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Boehringer Ingelheim
Study Sponsor	Boehringer Ingelheim
Collaborators	Not Provided
Investigators	Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account	Boehringer Ingelheim
Verification Date	March 2018