Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

GLORIA-AF Registry Program (Phase II/III)

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.
 
ClinicalTrials.gov Identifier: NCT01937377
Recruitment Status : Completed
First Posted : September 9, 2013
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.


Condition or disease
Stroke Atrial Fibrillation

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
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)
Actual Study Start Date : September 2, 2013
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


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
Layout table for location information
Switzerland
University Hospital 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
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01937377    
Other Study ID Numbers: 1160.171
First Posted: September 9, 2013    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes