GLORIA-AF Registry Program (Phase II/III)

Overview

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 three protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, 1160.136 for EU and EEA countries and 1160.171 for Switzerland. The total number of patients enrolled in three protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.

Full Title of Study: “GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III-India and Switzerland)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 15, 2019

Clinical Trial Outcome Measures

Primary Measures

  • Stroke (hemorrhagic and ischemic, uncertain classification)
    • Time Frame: up to 3 years
    • The analysis of the outcome measure is included in study 1160.129
  • Systemic embolism
    • Time Frame: up to 3 years
    • The analysis of the outcome measure is included in study 1160.129
  • Pulmonary embolism
    • Time Frame: up to 3 years
    • The analysis of the outcome measure is included in study 1160.129
  • Myocardial infarction
    • Time Frame: up to 3 years
    • The analysis of the outcome measure is included in study 1160.129
  • Life-threatening bleeding events
    • Time Frame: up to 3 years
    • The analysis of the outcome measure is included in study 1160.129
  • All cause death
    • Time Frame: up to 3 years
    • The analysis of the outcome measure is included in study 1160.129
  • Vascular death
    • Time Frame: up to 3 years
    • The analysis of the outcome measure is included in study 1160.129
  • Major bleeding events (including life-threatening bleeding events)
    • Time Frame: up to 3 years
    • The analysis of the outcome measure is included in study 1160.129
  • composite endpoint: Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death
    • Time Frame: up to 3 years
    • The analysis of the outcome measure is included in study 1160.129
  • composite endpoint: Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint)
    • Time Frame: up to 3 years
    • The analysis of the outcome measure is included in study 1160.129
  • Transient Ischemic Attack (TIA)
    • Time Frame: up to 3 years
    • The analysis of the outcome measure is included in study 1160.129

Participating in This Clinical Trial

Inclusion Criteria

1) Patients newly diagnosed with non-valvular atrial fibrillation (NVAF) at risk for stroke. Further 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. Further exclusion criteria apply

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

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