GLORIA-AF Registry Program (Phase II/III)
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| ClinicalTrials.gov Identifier: NCT01937377 |
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Recruitment Status :
Completed
First Posted : September 9, 2013
Last Update Posted : February 15, 2021
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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 |
| 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 |
- Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ]The analysis of the outcome measure is included in study 1160.129
- Systemic embolism [ Time Frame: up to 3 years ]The analysis of the outcome measure is included in study 1160.129
- Pulmonary embolism [ Time Frame: up to 3 years ]The analysis of the outcome measure is included in study 1160.129
- Myocardial infarction [ Time Frame: up to 3 years ]The analysis of the outcome measure is included in study 1160.129
- Life-threatening bleeding events [ Time Frame: up to 3 years ]The analysis of the outcome measure is included in study 1160.129
- All cause death [ Time Frame: up to 3 years ]The analysis of the outcome measure is included in study 1160.129
- Vascular death [ Time Frame: up to 3 years ]The analysis of the outcome measure is included in study 1160.129
- 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
- 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
- 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
- Transient Ischemic Attack (TIA) [ Time Frame: up to 3 years ]The analysis of the outcome measure is included in study 1160.129
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| 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 |
Inclusion criteria:
1) 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
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
| 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 | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |