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GLORIA-AF Registry Program - Second and Third Phases

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01468701
First received: October 28, 2011
Last updated: September 19, 2016
Last verified: September 2016
History of Changes

October 28, 2011
September 19, 2016
November 2011
January 2020   (final data collection date for primary outcome measure)
  • Myocardial infarction [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Life-threatening bleeding events [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • All cause death [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • composite endpoint: Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Transient Ischemic attack (TIA) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Systemic embolism [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Pulmonary embolism [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Major bleeding events (including life-threatening bleeding events) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Life-threatening bleeding events [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Major bleeding events [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • All cause death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Non-vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Death of unknown cause [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Age Group [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Gender [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • 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 ]
  • Transient Ischemic attack (TIA) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Systemic embolism [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Pulmonary embolism [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01468701 on ClinicalTrials.gov Archive Site
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GLORIA-AF Registry Program - Second and Third Phases
GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
patients with non-valvular AF
  • Stroke
  • Atrial Fibrillation
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
19000
January 2020
January 2020   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
United States,   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,   Venezuela
Croatia,   Puerto Rico,   Turkey
 
NCT01468701
1160.129
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Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
September 2016

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