Overview

This trial is active, not recruiting.

Conditions stroke, atrial fibrillation
Sponsor Boehringer Ingelheim
Start date September 2013
End date January 2020
Trial size 200 participants
Trial identifier NCT01937377, 1160.171

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Stroke (hemorrhagic and ischemic, uncertain classification)
time frame: up to 3 years
Systemic embolism
time frame: up to 3 years
Pulmonary embolism
time frame: up to 3 years
Myocardial infarction
time frame: up to 3 years
Life-threatening bleeding events
time frame: up to 3 years
All cause death
time frame: up to 3 years
Vascular death
time frame: up to 3 years
Major bleeding events (including life-threatening bleeding events)
time frame: up to 3 years
composite endpoint: Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death
time frame: up to 3 years
composite endpoint: Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint)
time frame: up to 3 years
Transient Ischemic Attack (TIA)
time frame: up to 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III-India and Switzerland)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.