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GLORIA-AF Registry Program - Second and Third Phases

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: October 28, 2011
Last updated: October 3, 2016
Last verified: October 2016
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.

Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 19000
Study Start Date: November 2011
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with non-valvular AF

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01468701

Contact: Boehringer Ingelheim Call Center 1-800-243-0127

  Show 696 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim Identifier: NCT01468701     History of Changes
Other Study ID Numbers: 1160.129 
Study First Received: October 28, 2011
Last Updated: October 3, 2016
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Brazil: Ministry of Health
Canada: Ethics Review Committee
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Ecuador: Public Health Ministry
Hong Kong: Department of Health
Japan: Ministry of Health, Labor and Welfare
Lebanon: Institutional Review Board
Mexico: Ministry of Health
Peru: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Saudi Arabia: Ministry of Health
Singapore: Clinical Trials and Epidemiology Research Unit (CTERU)
South Africa: Medicines Control Council
South Korea: Ministry of Food and Drug Safety (MFDS)
Taiwan: Institutional Review Board
United Arab Emirates: Drug Cont Dept-Med&Pharm Cont-Ministry of Health
United States: Institutional Review Board
Venezuela : Ministerio del Poder Popular para la Salud

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on January 17, 2017