GLORIA-AF Registry Program (Phase II/III)

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937377
• Other study ID #: 1160.171
• Status: Completed
• Start date: September 2, 2013
• Est. completion date: April 15, 2019

Study information

• Verified date: February 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Locations

Country	Name	City	State
Switzerland	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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Switzerland, 

Outcome

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

External Links

•   Results of this study are submitted together with study 1160.129