GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01671007
First received: August 20, 2012
Last updated: October 29, 2014
Last verified: October 2014

August 20, 2012
October 29, 2014
August 2012
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 ]
  • 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 ]
  • 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 ]
  • 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: 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 ]
  • 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 ]
  • vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • 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 ]
  • 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 ]
  • 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 ]
  • CHADS2 Score [cardiac failure, hypertension, age, diabetes, stroke (doubled)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • CHA2DS2VASc 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 ]
  • 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 ]
Complete list of historical versions of study NCT01671007 on ClinicalTrials.gov Archive Site
Not Provided
  • Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators outside the Summary of Product Characteristics (SmPC) indication. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
  • Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators with contraindications (overall and per contraindication captured) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
  • Phase II only: Percentage and characterization of dabigatran initiators with relevant comedications that should be used with caution [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
  • Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators without assessment of renal function (no serum creatinine reported) prior treatment initiation. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
  • Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators receiving 110 mg BID (twice daily) although 150 mg BID is recommended according to SmPC [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
  • Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators receiving 150 mg BID although 110 mg BID is recommended according to SmPC (e.g. patients > 80 years or patients with high bleeding risk) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
  • Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators without an interruption of dabigatran due to outcome events (e.g. major bleeds, major trauma), procedures. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)
GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase II/III - EU/EEA Member States)

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 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

patients with non-valvular AF

  • Stroke
  • Atrial Fibrillation
Not Provided
Not Provided
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
18875
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.

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
Both
18 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Netherlands,   Germany,   Spain,   El Salvador,   Croatia,   France,   Ireland,   Italy,   Norway,   Portugal,   Denmark,   Sweden,   United Kingdom,   Austria,   Bulgaria,   Latvia,   Estonia,   Romania,   Czech Republic,   Slovenia,   Greece,   Belgium,   Poland
 
NCT01671007
1160.136
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2014

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