GLORIA-AF Registry Program (Phase II/III)
11. februar 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Basel, Schweiz, 4031
- University Hospital Basel
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Lausanne, Schweiz, 1011
- CHUV - Centre Hospitalier Universitaire Vaudois
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Lugano, Schweiz, CH-6900
- Cardiocentro Ticino
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St. Gallen, Schweiz, 9007
- Kantonsspital St.Gallen
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Urtenen-Schonbuhl, Schweiz, 3322
- Arzte Zentrum Eigerpark, Urtenen-Schonbuhl
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
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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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. september 2013
Primær færdiggørelse (Faktiske)
15. april 2019
Studieafslutning (Faktiske)
15. april 2019
Datoer for studieregistrering
Først indsendt
4. september 2013
Først indsendt, der opfyldte QC-kriterier
4. september 2013
Først opslået (Skøn)
9. september 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. februar 2021
Sidst verificeret
1. februar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1160.171
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .