GLORIA-AF Registry Program (Phase II/III)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01937377
First received: September 4, 2013
Last updated: April 25, 2016
Last verified: April 2016

September 4, 2013
April 25, 2016
September 2013
January 2020   (final data collection date for primary outcome measure)
  • Stroke (hemorrhagic and ischemic, uncertain classification) [ 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 ]
  • 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 ]
  • Major bleeding events (including life-threatening bleeding events) [ 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 ]
  • composite endpoint: Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint) [ 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 ]
  • 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 ]
  • Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Transient Ischemic Attach (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 ]
  • 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 ]
  • 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 NCT01937377 on ClinicalTrials.gov Archive Site
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GLORIA-AF Registry Program (Phase II/III)
GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III-India and Switzerland)
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 three protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, 1160.136 for EU and EEA countries and 1160.171 for India and Switzerland. The total number of patients enrolled in three 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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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
January 2020
January 2020   (final data collection date for primary outcome measure)

Inclusion criteria:

1) Patients newly diagnosed with non-valvular atrial fibrillation (NVAF) at risk for stroke.

Further 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.

Further exclusion criteria apply

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01937377
1160.171
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Boehringer Ingelheim
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2016

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