GLORIA-AF Registry Program (Phase II/III)

February 11, 2021 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel
      • Lausanne, Switzerland, 1011
        • CHUV - Centre Hospitalier Universitaire Vaudois
      • Lugano, Switzerland, CH-6900
        • Cardiocentro Ticino
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St.Gallen
      • Urtenen-Schonbuhl, Switzerland, 3322
        • Arzte Zentrum Eigerpark, Urtenen-Schonbuhl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with non-valvular AF

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2013

Primary Completion (Actual)

April 15, 2019

Study Completion (Actual)

April 15, 2019

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 9, 2013

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.171

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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