GLORIA-AF Registry Program (Phase II/III)

Active, not recruiting

Phase N/A Results N/A

Trial Description

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 India and 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.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

patients with non-valvular AF

Outcomes

Type Measure Time Frame Safety Issue
Primary CHADS2 Score [cardiac failure, hypertension, age, diabetes, stroke (doubled)] 1 day No
Primary CHA2DS2-VASc Score [cardiac failure, hypertension, age >=75 (doubled), diabetes, stroke (doubled), vascular disease, age 65-74 and sex category (female) 1 day No
Primary HAS-BLED score [hypertension, abnormal renal/liver function (1 point each), stroke, bleeding history or predisposition, labile International Normalized Ratio (INR), elderly (>65), drugs/alcohol concomitantly (1 point each)] 1 day No
Primary Antithrombotic treatment choice at baseline 1 day No
Primary Stroke (hemorrhagic and ischemic, uncertain classification) up to 3 years Yes
Primary Transient Ischemic Attach (TIA) up to 3 years Yes
Primary Systemic embolism up to 3 years Yes
Primary Pulmonary embolism up to 3 years Yes
Primary Myocardial infarction up to 3 years Yes
Primary Life-threatening bleeding events up to 3 years Yes
Primary Major bleeding events up to 3 years Yes
Primary All cause death up to 3 years Yes
Primary Non-vascular death up to 3 years Yes
Primary Death of unknown cause up to 3 years Yes
Primary Vascular death up to 3 years Yes
Primary Composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death up to 3 years Yes
Primary Major bleeding events (including life-threatening bleeding events) up to 3 years Yes
Primary composite endpoint: Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint) up to 3 years No
Primary Transient Ischemic Attack (TIA) up to 3 years No

Sponsors