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StrokeNCT01937377

GLORIA-AF Registry Program (Phase II/III)

An observational study of Stroke and Atrial Fibrillation, run by Boehringer Ingelheim at 5 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Atrial Fibrillation
How many people
200 participants
Where
5 sitesSwitzerland
Study dates
2 Sep 2013to 15 Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients with non-valvular AF

Who may be able to join

  • 1) Patients newly diagnosed with non-valvular atrial fibrillation (NVAF) at risk for stroke.
  • Further inclusion criteria apply

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Switzerland5 sites

  • University Hospital Basel

    Basel, 4031

  • CHUV - Centre hospitalier universitaire vaudois

    Lausanne, 1011

  • Cardiocentro Ticino

    Lugano, CH-6900

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007

  • Arzte Zentrum Eigerpark, Urtenen-Schonbuhl

    Schönbühl, 3322

Other trials in Switzerland

About this study

Official title: 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.

Medical subject headings
Stroke, Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stroke (hemorrhagic and ischemic, uncertain classification)

    The analysis of the outcome measure is included in study 1160.129

    Measured: up to 3 years

  2. Systemic embolism

    The analysis of the outcome measure is included in study 1160.129

    Measured: up to 3 years

  3. Pulmonary embolism

    The analysis of the outcome measure is included in study 1160.129

    Measured: up to 3 years

  4. Myocardial infarction

    The analysis of the outcome measure is included in study 1160.129

    Measured: up to 3 years

  5. Life-threatening bleeding events

    The analysis of the outcome measure is included in study 1160.129

    Measured: up to 3 years

  6. All cause death

    The analysis of the outcome measure is included in study 1160.129

    Measured: up to 3 years

  7. Vascular death

    The analysis of the outcome measure is included in study 1160.129

    Measured: up to 3 years

  8. Major bleeding events (including life-threatening bleeding events)

    The analysis of the outcome measure is included in study 1160.129

    Measured: up to 3 years

  9. 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

    Measured: up to 3 years

  10. 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

    Measured: up to 3 years

  11. Transient Ischemic Attack (TIA)

    The analysis of the outcome measure is included in study 1160.129

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2013 (estimated)
  2. Study start2 Sep 2013
  3. Primary completion15 Apr 2019
  4. Study completion15 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01937377
Sponsor's protocol ID
1160.171
Status last verified
Feb 2021
First submitted
4 Sep 2013
Last updated
15 Feb 2021
Results posted
No

Publications

  • 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.

    PubMed 39511367

  • 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.

    PubMed 37753446

  • 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.

    PubMed 37566295

  • 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.

    PubMed 35876418

  • 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.

    PubMed 35488127

  • 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.

    PubMed 33912651

  • 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.

    PubMed 33338644

  • 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.

    PubMed 29653649

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Atrial Fibrillation, run by Boehringer Ingelheim at 5 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke (hemorrhagic and ischemic, uncertain classification) (time frame: up to 3 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01937377, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.

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GLORIA-AF Registry Program (Phase II/III) | AzTrials