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GLORIA-AF Registry Program - Second and Third Phases

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01468701
First received: October 28, 2011
Last updated: March 27, 2017
Last verified: March 2017
  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 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.

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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Myocardial infarction [ Time Frame: up to 3 years ]
  • Life-threatening bleeding events [ Time Frame: up to 3 years ]
  • All cause death [ Time Frame: up to 3 years ]
  • Vascular death [ Time Frame: up to 3 years ]
  • composite endpoint: Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint) [ Time Frame: up to 3 years ]
  • Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ]
  • Transient Ischemic attack (TIA) [ Time Frame: up to 3 years ]
  • Systemic embolism [ Time Frame: up to 3 years ]
  • Pulmonary embolism [ Time Frame: up to 3 years ]
  • composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ]
  • Major bleeding events (including life-threatening bleeding events) [ Time Frame: up to 3 years ]

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)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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: NCT01468701

  Show 506 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: NCT01468701     History of Changes
Other Study ID Numbers: 1160.129
Study First Received: October 28, 2011
Last Updated: March 27, 2017

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

ClinicalTrials.gov processed this record on April 25, 2017