- ICH GCP
- US-Register für klinische Studien
- Klinische 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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
-
Basel, Schweiz, 4031
- University Hospital Basel
-
Lausanne, Schweiz, 1011
- CHUV - Centre Hospitalier Universitaire Vaudois
-
Lugano, Schweiz, CH-6900
- Cardiocentro Ticino
-
St. Gallen, Schweiz, 9007
- Kantonsspital St.Gallen
-
Urtenen-Schonbuhl, Schweiz, 3322
- Arzte Zentrum Eigerpark, Urtenen-Schonbuhl
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Stroke (hemorrhagic and ischemic, uncertain classification)
Zeitfenster: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Systemic embolism
Zeitfenster: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Pulmonary embolism
Zeitfenster: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Myocardial infarction
Zeitfenster: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Life-threatening bleeding events
Zeitfenster: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
All cause death
Zeitfenster: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Vascular death
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Transient Ischemic Attack (TIA)
Zeitfenster: up to 3 years
|
The analysis of the outcome measure is included in study 1160.129
|
up to 3 years
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1160.171
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .