- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01937377
GLORIA-AF Registry Program (Phase II/III)
GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III-India and Switzerland)
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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
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Basel, Švýcarsko, 4031
- University Hospital Basel
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Lausanne, Švýcarsko, 1011
- CHUV - Centre Hospitalier Universitaire Vaudois
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Lugano, Švýcarsko, CH-6900
- CardioCentro Ticino
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St. Gallen, Švýcarsko, 9007
- Kantonsspital St.Gallen
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Urtenen-Schonbuhl, Švýcarsko, 3322
- Arzte Zentrum Eigerpark, Urtenen-Schonbuhl
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Stroke (hemorrhagic and ischemic, uncertain classification)
Časové okno: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Systemic embolism
Časové okno: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Pulmonary embolism
Časové okno: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Myocardial infarction
Časové okno: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Life-threatening bleeding events
Časové okno: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
All cause death
Časové okno: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Vascular death
Časové okno: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Major bleeding events (including life-threatening bleeding events)
Časové okno: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
composite endpoint: Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death
Časové okno: up to 3 years
|
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)
Časové okno: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Transient Ischemic Attack (TIA)
Časové okno: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1160.171
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