GLORIA-AF Registry Program (Phase II/III)

Completed

• Conditions: Stroke; Atrial Fibrillation

• Registration Number: NCT01937377
• Lead Sponsor: 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-02
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-09
• Primary Completion: 2019-04-15
• Study Completion: 2019-04-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (5)

University Hospital Basel; 🇨🇭 Basel, Switzerland

CHUV - Centre hospitalier universitaire vaudois; 🇨🇭 Lausanne, Switzerland

Cardiocentro Ticino; 🇨🇭 Lugano, Switzerland

Kantonsspital St.Gallen; 🇨🇭 St. Gallen, Switzerland

Arzte Zentrum Eigerpark, Urtenen-Schonbuhl; 🇨🇭 Urtenen-Schonbuhl, Switzerland