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GLORIA-AF Registry Program (Phase II/III)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01937377
First Posted: September 9, 2013
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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.

Condition
Stroke Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III-India and Switzerland)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Actual Study Start Date: September 2, 2013
Estimated Study Completion Date: January 14, 2020
Estimated Primary Completion Date: January 14, 2020 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with non-valvular AF
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937377


Locations
Switzerland
Universitätsspital Basel
Basel, Switzerland, 4031
CHUV - Centre hospitalier universitaire vaudois
Lausanne, Switzerland, 1011
Cardiocentro Ticino
Lugano, Switzerland, CH-6900
Kantonsspital St.Gallen
St. Gallen, Switzerland, 9007
Arzte Zentrum Eigerpark, Urtenen-Schonbuhl
Urtenen-Schonbuhl, Switzerland, 3322
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01937377     History of Changes
Other Study ID Numbers: 1160.171
First Submitted: September 4, 2013
First Posted: September 9, 2013
Last Update Posted: August 28, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes