GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States) - Full Text View

Purpose

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 two protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.

Condition
Stroke Atrial Fibrillation

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase II/III - EU/EEA Member States)

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Heart Attack High Blood Pressure

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

CHADS2 Score [cardiac failure, hypertension, age, diabetes, stroke (doubled)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
CHA2DS2VASc Score [cardiac failure, hypertension, age >=75 (doubled), diabetes, stroke (doubled), vascular disease, age 65-74 and sex category (female)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
HAS-BLED score [hypertension, abnormal renal/liver function (1 point each), stroke, bleeding history or predisposition, labile international Normalized Ratio (INR), elderly (>65), drugs/alcohol concomitantly (1 point each)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Antithrombotic treatment choice at baseline [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
Transient ischemic attack (TIA) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
systemic embolism [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
pulmonary embolism [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
myocardial infarction [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
life-threatening bleeding events [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
Major bleeding events [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
All cause death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
Non-vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
Death of unknown cause [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators outside the Summary of Product Characteristics (SmPC) indication. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators with contraindications (overall and per contraindication captured) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
Phase II only: Percentage and characterization of dabigatran initiators with relevant comedications that should be used with caution [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators without assessment of renal function (no serum creatinine reported) prior treatment initiation. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators receiving 110 mg BID (twice daily) although 150 mg BID is recommended according to SmPC [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators receiving 150 mg BID although 110 mg BID is recommended according to SmPC (e.g. patients > 80 years or patients with high bleeding risk) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators without an interruption of dabigatran due to outcome events (e.g. major bleeds, major trauma), procedures. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20540
Study Start Date:	August 2012
Estimated Study Completion Date:	August 2020
Estimated Primary Completion Date:	August 2020 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients with non-valvular AF

Criteria

Inclusion criteria:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671007

Contacts

Contact: Boehringer Ingelheim Call Center

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Show 272 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01671007 History of Changes
Other Study ID Numbers:	1160.136
Study First Received:	August 20, 2012
Last Updated:	May 2, 2013
Health Authority:	Austria: Medicines and Medical Devices Agency Bulgaria: Bulgarian Drug Agency Croatia: Agency for Medicinal Product and Medical Devices Czech Republic: State Institute for Drug Control Denmark: Danish Dataprotection Agency Estonia: The State Agency of Medicine France: French Data Protection Authority Germany: Ethics Commission Greece: Ethics Committee Ireland: Irish Medicines Board Italy: Ethics Committee Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Netherlands: Medical Ethics Review Committee (METC) Norway:National Committee for Medical and Health Research Ethics Portugal: National Pharmacy and Medicines Institute Romania: National Medicines Agency Slovenia: Agency for Medicinal Products - Ministry of Health Spain: Spanish Agency of Medicines Sweden: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013