GLORIA-AF Registry Program (Phase II/III)
11. februar 2021 oppdatert av: Boehringer Ingelheim
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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Basel, Sveits, 4031
- University Hospital Basel
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Lausanne, Sveits, 1011
- CHUV - Centre Hospitalier Universitaire Vaudois
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Lugano, Sveits, CH-6900
- Cardiocentro Ticino
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St. Gallen, Sveits, 9007
- Kantonsspital St.Gallen
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Urtenen-Schonbuhl, Sveits, 3322
- Arzte Zentrum Eigerpark, Urtenen-Schonbuhl
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
patients with non-valvular AF
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Stroke (hemorrhagic and ischemic, uncertain classification)
Tidsramme: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
|
Systemic embolism
Tidsramme: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
|
Pulmonary embolism
Tidsramme: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
|
Myocardial infarction
Tidsramme: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
|
Life-threatening bleeding events
Tidsramme: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
|
All cause death
Tidsramme: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
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Vascular death
Tidsramme: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
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up to 3 years
|
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Major bleeding events (including life-threatening bleeding events)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
|
Transient Ischemic Attack (TIA)
Tidsramme: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. september 2013
Primær fullføring (Faktiske)
15. april 2019
Studiet fullført (Faktiske)
15. april 2019
Datoer for studieregistrering
Først innsendt
4. september 2013
Først innsendt som oppfylte QC-kriteriene
4. september 2013
Først lagt ut (Anslag)
9. september 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. februar 2021
Sist bekreftet
1. februar 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1160.171
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