GLORIA-AF Registry Program (Phase I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01428765
First received: August 25, 2011
Last updated: May 2, 2013
Last verified: May 2013

August 25, 2011
May 2, 2013
May 2011
January 2013   (final data collection date for primary outcome measure)
  • CHADS2 Score [cardiac failure, hypertension, age, diabetes, stroke (doubled)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Antithrombotic treatment choice at baseline [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Gender [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Age group [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01428765 on ClinicalTrials.gov Archive Site
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GLORIA-AF Registry Program (Phase I)
GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase I)

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.

Study Design:

cross-sectional

Observational
Time Perspective: Cross-Sectional
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Non-Probability Sample

adult patients with non-valvular atrial fibrillation at risk for stroke

Atrial Fibrillation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1096
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Croatia,   Egypt,   Germany,   Lebanon,   Netherlands,   Spain,   Turkey
 
NCT01428765
1160.114
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Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP