Clinical trial NCT01937377: GLORIA-AF Registry Program (Phase II/III)
Official title: GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III-India and Switzerland)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-09-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with non-valvular AF

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

1) Patients newly diagnosed with non-valvular atrial fibrillation (NVAF) at risk for stroke.

Further inclusion criteria apply

Exclusion criteria:

1. Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
2. Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
3. AF with a generally reversible cause;
4. 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

Primary outcomes:
measure: Stroke (hemorrhagic and ischemic, uncertain classification)
timeFrame: up to 3 years
measure: Systemic embolism
timeFrame: up to 3 years
measure: Pulmonary embolism
timeFrame: up to 3 years
measure: Myocardial infarction
timeFrame: up to 3 years
measure: Life-threatening bleeding events
timeFrame: up to 3 years
measure: All cause death
timeFrame: up to 3 years
measure: Vascular death
timeFrame: up to 3 years
measure: Major bleeding events (including life-threatening bleeding events)
timeFrame: up to 3 years
measure: composite endpoint: Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death
timeFrame: up to 3 years
measure: composite endpoint: Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint)
timeFrame: up to 3 years
measure: Transient Ischemic Attack (TIA)
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Lausanne
country: Switzerland
facility: CHUV - Centre hospitalier universitaire vaudois
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: St. Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Urtenen-Schonbuhl
country: Switzerland
facility: Arzte Zentrum Eigerpark, Urtenen-Schonbuhl
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.