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GLORIA-AF Registry Program (Phase I)

NCT ID: NCT01428765

Last Updated: 2014-03-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1096 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Study Design:

cross-sectional

Conditions

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Atrial Fibrillation

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.114.08017 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1160.114.08018 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1160.114.08019 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1160.114.08020 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1160.114.08023 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1160.114.08024 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1160.114.08025 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1160.114.08007 Boehringer Ingelheim Investigational Site

Changsha, , China

Site Status

1160.114.08021 Boehringer Ingelheim Investigational Site

Dalian, , China

Site Status

1160.114.08004 Boehringer Ingelheim Investigational Site

Ghuangzhou, , China

Site Status

1160.114.08006 Boehringer Ingelheim Investigational Site

Ghuangzhou, , China

Site Status

1160.114.08001 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1160.114.08002 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1160.114.08005 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1160.114.08011 Boehringer Ingelheim Investigational Site

Hangzhou, , China

Site Status

1160.114.08015 Boehringer Ingelheim Investigational Site

Hangzhou, , China

Site Status

1160.114.08026 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1160.114.08010 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1160.114.08012 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1160.114.08014 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1160.114.08016 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1160.114.08027 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1160.114.08028 Boehringer Ingelheim Investigational Site

Shenzhen, , China

Site Status

1160.114.08022 Boehringer Ingelheim Investigational Site

Tianjin, , China

Site Status

1160.114.08008 Boehringer Ingelheim Investigational Site

Wuhan, , China

Site Status

1160.114.04002 Boehringer Ingelheim Investigational Site

Krapinske Toplice, , Croatia

Site Status

1160.114.04001 Boehringer Ingelheim Investigational Site

Opatija, , Croatia

Site Status

1160.114.04003 Boehringer Ingelheim Investigational Site

Zagreb, , Croatia

Site Status

1160.114.04004 Boehringer Ingelheim Investigational Site

Zagreb, , Croatia

Site Status

1160.114.28001 Boehringer Ingelheim Investigational Site

Cairo, , Egypt

Site Status

1160.114.490201 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1160.114.490216 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1160.114.490220 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1160.114.490217 Boehringer Ingelheim Investigational Site

Dessau, , Germany

Site Status

1160.114.490214 Boehringer Ingelheim Investigational Site

Dinslaken, , Germany

Site Status

1160.114.490215 Boehringer Ingelheim Investigational Site

Halle, , Germany

Site Status

1160.114.490206 Boehringer Ingelheim Investigational Site

Itzehoe, , Germany

Site Status

1160.114.490209 Boehringer Ingelheim Investigational Site

Kempen, , Germany

Site Status

1160.114.490208 Boehringer Ingelheim Investigational Site

Ludwigsburg, , Germany

Site Status

1160.114.490212 Boehringer Ingelheim Investigational Site

Markkleeberg, , Germany

Site Status

1160.114.490207 Boehringer Ingelheim Investigational Site

Mühldorf, , Germany

Site Status

1160.114.490210 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

1160.114.490202 Boehringer Ingelheim Investigational Site

Northeim, , Germany

Site Status

1160.114.490204 Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

Site Status

1160.114.490211 Boehringer Ingelheim Investigational Site

Wittenberg, , Germany

Site Status

1160.114.07001 Boehringer Ingelheim Investigational Site

Beirut, , Lebanon

Site Status

1160.114.31013 Boehringer Ingelheim Investigational Site

Deventer, , Netherlands

Site Status

1160.114.31008 Boehringer Ingelheim Investigational Site

Enschede, , Netherlands

Site Status

1160.114.31005 Boehringer Ingelheim Investigational Site

Maastricht, , Netherlands

Site Status

1160.114.34012 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1160.114.34004 Boehringer Ingelheim Investigational Site

Jaén, , Spain

Site Status

1160.114.34010 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.114.34003 Boehringer Ingelheim Investigational Site

Málaga, , Spain

Site Status

1160.114.34005 Boehringer Ingelheim Investigational Site

Murcia, , Spain

Site Status

1160.114.34013 Boehringer Ingelheim Investigational Site

Sabadell (Barcelona), , Spain

Site Status

1160.114.34011 Boehringer Ingelheim Investigational Site

Santiago de Compostela, , Spain

Site Status

1160.114.34001 Boehringer Ingelheim Investigational Site

Seville, , Spain

Site Status

1160.114.34006 Boehringer Ingelheim Investigational Site

Seville, , Spain

Site Status

1160.114.09004 Boehringer Ingelheim Investigational Site

Adana, , Turkey (Türkiye)

Site Status

1160.114.09001 Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

1160.114.09006 Boehringer Ingelheim Investigational Site

Antalya, , Turkey (Türkiye)

Site Status

1160.114.09009 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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China Croatia Egypt Germany Lebanon Netherlands Spain Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 24576516 (View on PubMed)

Other Identifiers

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1160.114

Identifier Type: -

Identifier Source: org_study_id

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