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Completed

NCT Number: NCT01937377

GLORIA-AF Registry Program (Phase II/III)

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.

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Key information

Conditions

Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Basel, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients newly diagnosed with non-valvular atrial fibrillation (NVAF) at risk for stroke.

Further inclusion criteria apply

Exclusion criteria

  • Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
  • Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
  • AF with a generally reversible cause;
  • 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

Treatment and study plan

Primary outcomes

  1. Stroke (hemorrhagic and ischemic, uncertain classification)

    Time frame: up to 3 years

    The analysis of the outcome measure is included in study 1160.129

  2. Systemic embolism

    Time frame: up to 3 years

    The analysis of the outcome measure is included in study 1160.129

  3. Pulmonary embolism

    Time frame: up to 3 years

    The analysis of the outcome measure is included in study 1160.129

  4. Myocardial infarction

    Time frame: up to 3 years

    The analysis of the outcome measure is included in study 1160.129

  5. Life-threatening bleeding events

    Time frame: up to 3 years

    The analysis of the outcome measure is included in study 1160.129

  6. All cause death

    Time frame: up to 3 years

    The analysis of the outcome measure is included in study 1160.129

  7. Vascular death

    Time frame: up to 3 years

    The analysis of the outcome measure is included in study 1160.129

  8. 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

  9. 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

  10. 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

  11. Transient Ischemic Attack (TIA)

    Time frame: up to 3 years

    The analysis of the outcome measure is included in study 1160.129

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2013
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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