Clinical trial NCT01428765: GLORIA-AF Registry Program (Phase I)
Official title: GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase I)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-09-05
Enrollment: 1096
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with non-valvular atrial fibrillation at risk for stroke

Brief summary: This study constitutes Phase I of the Registry Program. The main objective of this study is to characterize the newly diagnosed non-valvular AF patient population at risk for stroke and the selection of antithrombotic treatment for stroke prevention in a real-world setting before dabigatran etexilate is approved for the prevention of strokes and systemic emboli in patients with non-valvular AF in different regions of the world.

Detailed description: Study Design:

cross-sectional

Eligibility criteria: Inclusion criteria:

1) Patients newly diagnosed with non-valvular atrial fibrillation 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 oral anticoagulant treatment (vitamin K antagonist) (VKA) in their lifetime;
3. Atrial fibrillation (AF) with a generally reversible cause;
4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (VKAs) is indicated

Primary outcomes:
measure: CHADS2 Score
timeFrame: Baseline
measure: CHA2DS2-VASc Score
timeFrame: Baseline
measure: HAS-BLED Risk Score
timeFrame: Baseline
measure: Antithrombotic Treatment Choice at Baseline
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Age Group
timeFrame: Baseline
measure: Medical History
timeFrame: Baseline
measure: Concomitant Medication
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: 1160.114.08017 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1160.114.08018 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1160.114.08019 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1160.114.08020 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1160.114.08023 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1160.114.08024 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1160.114.08025 Boehringer Ingelheim Investigational Site
city: Changsha
country: China
facility: 1160.114.08007 Boehringer Ingelheim Investigational Site
city: Dalian
country: China
facility: 1160.114.08021 Boehringer Ingelheim Investigational Site
city: Ghuangzhou
country: China
facility: 1160.114.08004 Boehringer Ingelheim Investigational Site
city: Ghuangzhou
country: China
facility: 1160.114.08006 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1160.114.08001 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1160.114.08002 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1160.114.08005 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 1160.114.08011 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 1160.114.08015 Boehringer Ingelheim Investigational Site
city: Nanjing
country: China
facility: 1160.114.08026 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.114.08010 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.114.08012 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.114.08014 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.114.08016 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.114.08027 Boehringer Ingelheim Investigational Site
city: Shenzhen
country: China
facility: 1160.114.08028 Boehringer Ingelheim Investigational Site
city: Tianjin
country: China
facility: 1160.114.08022 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 1160.114.08008 Boehringer Ingelheim Investigational Site
city: Krapinske Toplice
country: Croatia
facility: 1160.114.04002 Boehringer Ingelheim Investigational Site
city: Opatija
country: Croatia
facility: 1160.114.04001 Boehringer Ingelheim Investigational Site
city: Zagreb
country: Croatia
facility: 1160.114.04003 Boehringer Ingelheim Investigational Site
city: Zagreb
country: Croatia
facility: 1160.114.04004 Boehringer Ingelheim Investigational Site
city: Cairo
country: Egypt
facility: 1160.114.28001 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1160.114.490201 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1160.114.490216 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1160.114.490220 Boehringer Ingelheim Investigational Site
city: Dessau-Roßlau
country: Germany
facility: 1160.114.490217 Boehringer Ingelheim Investigational Site
city: Dinslaken
country: Germany
facility: 1160.114.490214 Boehringer Ingelheim Investigational Site
city: Halle
country: Germany
facility: 1160.114.490215 Boehringer Ingelheim Investigational Site
city: Itzehoe
country: Germany
facility: 1160.114.490206 Boehringer Ingelheim Investigational Site
city: Kempen
country: Germany
facility: 1160.114.490209 Boehringer Ingelheim Investigational Site
city: Ludwigsburg
country: Germany
facility: 1160.114.490208 Boehringer Ingelheim Investigational Site
city: Markkleeberg
country: Germany
facility: 1160.114.490212 Boehringer Ingelheim Investigational Site
city: Mühldorf
country: Germany
facility: 1160.114.490207 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1160.114.490210 Boehringer Ingelheim Investigational Site
city: Northeim
country: Germany
facility: 1160.114.490202 Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: 1160.114.490204 Boehringer Ingelheim Investigational Site
city: Wittenberg
country: Germany
facility: 1160.114.490211 Boehringer Ingelheim Investigational Site
city: Beirut
country: Lebanon
facility: 1160.114.07001 Boehringer Ingelheim Investigational Site
city: Deventer
country: Netherlands
facility: 1160.114.31013 Boehringer Ingelheim Investigational Site
city: Enschede
country: Netherlands
facility: 1160.114.31008 Boehringer Ingelheim Investigational Site
city: Maastricht
country: Netherlands
facility: 1160.114.31005 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1160.114.34012 Boehringer Ingelheim Investigational Site
city: Jaén
country: Spain
facility: 1160.114.34004 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.114.34010 Boehringer Ingelheim Investigational Site
city: Murcia
country: Spain
facility: 1160.114.34005 Boehringer Ingelheim Investigational Site
city: Málaga
country: Spain
facility: 1160.114.34003 Boehringer Ingelheim Investigational Site
city: Sabadell (Barcelona)
country: Spain
facility: 1160.114.34013 Boehringer Ingelheim Investigational Site
city: Santiago de Compostela
country: Spain
facility: 1160.114.34011 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 1160.114.34001 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 1160.114.34006 Boehringer Ingelheim Investigational Site
city: Adana
country: Turkey
facility: 1160.114.09004 Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: 1160.114.09001 Boehringer Ingelheim Investigational Site
city: Antalya
country: Turkey
facility: 1160.114.09006 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.114.09009 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.