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

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:
NCT01671007
First received: August 20, 2012
Last updated: September 5, 2016
Last verified: September 2016
History of Changes
  Purpose
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.

Condition
Stroke
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 - EU/EEA Member States)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]
  • All cause death [ 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 (including life-threatening bleeding events) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Vascular death [ 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 ]
Estimated Enrollment: 18875
Study Start Date: August 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with non-valvular AF
Criteria

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 ClinicalTrials.gov identifier: NCT01671007

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 543 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01671007     History of Changes
Other Study ID Numbers: 1160.136 
Study First Received: August 20, 2012
Last Updated: September 5, 2016
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Bulgaria: Bulgarian Drug Agency
Croatia: Agency for Medicinal Product and Medical Devices
Czech Republic: State Institute for Drug Control
Denmark: Danish Dataprotection Agency
Estonia: The State Agency of Medicine
France: French Data Protection Authority
Germany: Ethics Commission
Greece: Ethics Committee
Ireland: Irish Medicines Board
Italy: AIFA (Italian Medicine Agency)
Latvia: State Agency of Medicines
Netherlands: Medical Ethics Review Committee (METC)
Norway:National Committee for Medical and Health Research Ethics
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Portugal: INFARMED, National Authority of Medicines and Health Products, IP

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2016