GLORIA-AF Registry Program (Phase II/III)

NCT01937377 | Completed

• 1 other identifier: 1160.171
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Stroke; Atrial Fibrillation

Outcome Measures

Primary Outcomes (11)

• Stroke (hemorrhagic and ischemic, uncertain classification)

  The analysis of the outcome measure is included in study 1160.129

  up to 3 years

• Systemic embolism

  The analysis of the outcome measure is included in study 1160.129

  up to 3 years

• Pulmonary embolism

  The analysis of the outcome measure is included in study 1160.129

  up to 3 years

• Myocardial infarction

  The analysis of the outcome measure is included in study 1160.129

  up to 3 years

• Life-threatening bleeding events

  The analysis of the outcome measure is included in study 1160.129

  up to 3 years

• All cause death

  The analysis of the outcome measure is included in study 1160.129

  up to 3 years

• Vascular death

  The analysis of the outcome measure is included in study 1160.129

  up to 3 years

• Major bleeding events (including life-threatening bleeding events)

  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

  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)

  The analysis of the outcome measure is included in study 1160.129

  up to 3 years

• Transient Ischemic Attack (TIA)

  The analysis of the outcome measure is included in study 1160.129

  up to 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with non-valvular AF

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (5)

University Hospital Basel

Basel, 4031, Switzerland

Location

CHUV - Centre hospitalier universitaire vaudois

Lausanne, 1011, Switzerland

Location

Cardiocentro Ticino

Lugano, CH-6900, Switzerland

Location

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

Arzte Zentrum Eigerpark, Urtenen-Schonbuhl

Schönbühl, 3322, Switzerland

Location

Related Publications (8)

• Joddrell M, El-Bouri W, Harrison SL, Huisman MV, Lip GYH, Zheng Y; GLORIA-AFinvestigators. Machine learning for outcome prediction in patients with non-valvular atrial fibrillation from the GLORIA-AF registry. Sci Rep. 2024 Nov 7;14(1):27088. doi: 10.1038/s41598-024-78120-z.

  PMID: 39511367 DERIVED

• Romiti GF, Corica B, Proietti M, Mei DA, Frydenlund J, Bisson A, Boriani G, Olshansky B, Chan YH, Huisman MV, Chao TF, Lip GYH; GLORIA-AF Investigators. Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation: a post-hoc analysis from the GLORIA-AF Registry. EClinicalMedicine. 2023 Aug 25;63:102039. doi: 10.1016/j.eclinm.2023.102039. eCollection 2023 Sep.

  PMID: 37753446 DERIVED

• Ding WY, Fawzy AM, Romiti GF, Proietti M, Pastori D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Validating the predictive ability of the 2MACE score for major adverse cardiovascular events in patients with atrial fibrillation: results from phase II/III of the GLORIA-AF registry. J Thromb Thrombolysis. 2024 Jan;57(1):39-49. doi: 10.1007/s11239-023-02866-y. Epub 2023 Aug 11.

  PMID: 37566295 DERIVED

• 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.

  PMID: 35876418 DERIVED

• 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.

  PMID: 35488127 DERIVED

• 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.

  PMID: 33912651 DERIVED

• 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.

  PMID: 33338644 DERIVED

• 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.

  PMID: 29653649 DERIVED

Related Links

• Results of this study are submitted together with study 1160.129

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 9, 2013
• Study Start: September 2, 2013
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

CH (5)