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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Stroke (hemorrhagic and ischemic, uncertain classification) | The analysis of the outcome measure is included in study 1160.129 | up to 3 years |
| Systemic embolism | The analysis of the outcome measure is included in study 1160.129 | up to 3 years |
| Pulmonary embolism | The analysis of the outcome measure is included in study 1160.129 | up to 3 years |
| Myocardial infarction | The analysis of the outcome measure is included in study 1160.129 | up to 3 years |
| Life-threatening bleeding events | The analysis of the outcome measure is included in study 1160.129 | up to 3 years |
| All cause death | The analysis of the outcome measure is included in study 1160.129 | up to 3 years |
| Vascular death | The analysis of the outcome measure is included in study 1160.129 | up to 3 years |
| Major bleeding events (including life-threatening bleeding events) | The analysis of the outcome measure is included in study 1160.129 |
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Inclusion criteria:
1) Patients newly diagnosed with non-valvular atrial fibrillation (NVAF) at risk for stroke.
Further inclusion criteria apply
Exclusion criteria:
Further exclusion criteria apply
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patients with non-valvular AF
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland | |||
| CHUV - Centre hospitalier universitaire vaudois |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39511367 | Derived | Joddrell M, El-Bouri W, Harrison SL, Huisman MV, Lip GYH, Zheng Y; GLORIA-AFinvestigators. Machine learning for outcome prediction in patients with non-valvular atrial fibrillation from the GLORIA-AF registry. Sci Rep. 2024 Nov 7;14(1):27088. doi: 10.1038/s41598-024-78120-z. | |
| 37753446 | Derived | Romiti GF, Corica B, Proietti M, Mei DA, Frydenlund J, Bisson A, Boriani G, Olshansky B, Chan YH, Huisman MV, Chao TF, Lip GYH; GLORIA-AF Investigators. Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation: a post-hoc analysis from the GLORIA-AF Registry. EClinicalMedicine. 2023 Aug 25;63:102039. doi: 10.1016/j.eclinm.2023.102039. eCollection 2023 Sep. |
| Label | URL |
|---|---|
| Results of this study are submitted together with study 1160.129 | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| up to 3 years |
| composite endpoint: Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death | 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) | The analysis of the outcome measure is included in study 1160.129 | up to 3 years |
| Transient Ischemic Attack (TIA) | The analysis of the outcome measure is included in study 1160.129 | up to 3 years |
| Lausanne |
| 1011 |
| Switzerland |
| Cardiocentro Ticino | Lugano | CH-6900 | Switzerland |
| Kantonsspital St.Gallen | Sankt Gallen | 9007 | Switzerland |
| Arzte Zentrum Eigerpark, Urtenen-Schonbuhl | Schönbühl | 3322 | Switzerland |
| 37566295 | Derived | Ding WY, Fawzy AM, Romiti GF, Proietti M, Pastori D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Validating the predictive ability of the 2MACE score for major adverse cardiovascular events in patients with atrial fibrillation: results from phase II/III of the GLORIA-AF registry. J Thromb Thrombolysis. 2024 Jan;57(1):39-49. doi: 10.1007/s11239-023-02866-y. Epub 2023 Aug 11. |
| 35876418 | Derived | Ding WY, Lane DA, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Incidence and Risk Factors for Residual Adverse Events Despite Anticoagulation in Atrial Fibrillation: Results From Phase II/III of the GLORIA-AF Registry. J Am Heart Assoc. 2022 Aug 2;11(15):e026410. doi: 10.1161/JAHA.122.026410. Epub 2022 Jul 25. |
| 35488127 | Derived | Ding WY, Calvert P, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Impact of early ablation of atrial fibrillation on long-term outcomes: results from phase II/III of the GLORIA-AF registry. Clin Res Cardiol. 2022 Sep;111(9):1057-1068. doi: 10.1007/s00392-022-02022-1. Epub 2022 Apr 29. |
| 33912651 | Derived | Azar RR, Ragy HI, Kozan O, El Khuri M, Bazergani N, Marler S, Teutsch C, Ibrahim M, Lip GYH, Huisman MV. Antithrombotic treatment pattern in newly diagnosed atrial fibrillation patients and 2-year follow-up results for dabigatran-treated patients in the Africa/Middle-East Region: Phase II results from the GLORIA-AF registry program. Int J Cardiol Heart Vasc. 2021 Apr 10;34:100763. doi: 10.1016/j.ijcha.2021.100763. eCollection 2021 Jun. |
| 33338644 | Derived | Ntaios G, Huisman MV, Diener HC, Halperin JL, Teutsch C, Marler S, Gurusamy VK, Thompson M, Lip GYH, Olshansky B; GLORIA-AF Investigators. Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation: The GLORIA-AF registry. Hellenic J Cardiol. 2021 Mar-Apr;62(2):152-157. doi: 10.1016/j.hjc.2020.11.009. Epub 2020 Dec 15. |
| 29653649 | Derived | Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Zint K, Elsaesser A, Lu S, Bartels DB, Lip GYH; GLORIA-AF Investigators. Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry. Am Heart J. 2018 Apr;198:55-63. doi: 10.1016/j.ahj.2017.08.018. Epub 2017 Aug 31. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |