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GLORIA-AF Registry Program - Second and Third Phases

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ClinicalTrials.gov Identifier: NCT01468701
Recruitment Status : Active, not recruiting
First Posted : November 9, 2011
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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 or disease
Stroke Atrial Fibrillation

Study Type : Observational
Estimated Enrollment : 19000 participants
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)
Actual Study Start Date : November 7, 2011
Estimated Primary Completion Date : January 14, 2020
Estimated Study Completion Date : January 14, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468701


  Show 685 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim