GLORIA-AF Registry Program - Second and Third Phases

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT01468701

First received: October 28, 2011

Last updated: March 27, 2017

Last verified: March 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

October 28, 2011

Last Updated Date

March 27, 2017

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Myocardial infarction [ Time Frame: up to 3 years ]
Life-threatening bleeding events [ Time Frame: up to 3 years ]
All cause death [ Time Frame: up to 3 years ]
Vascular death [ Time Frame: up to 3 years ]
composite endpoint: Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint) [ Time Frame: up to 3 years ]
Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ]
Transient Ischemic attack (TIA) [ Time Frame: up to 3 years ]
Systemic embolism [ Time Frame: up to 3 years ]
Pulmonary embolism [ Time Frame: up to 3 years ]
composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ]
Major bleeding events (including life-threatening bleeding events) [ Time Frame: up to 3 years ]

Original Primary Outcome Measures ^ICMJE

Myocardial infarction [ Time Frame: up to 3 years ]
Life-threatening bleeding events [ Time Frame: up to 3 years ]
Major bleeding events [ Time Frame: up to 3 years ]
All cause death [ Time Frame: up to 3 years ]
Non-vascular death [ Time Frame: up to 3 years ]
Death of unknown cause [ Time Frame: up to 3 years ]
vascular death [ Time Frame: up to 3 years ]
Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ]
Age Group [ Time Frame: 1 day ]
Gender [ Time Frame: 1 day ]
CHADS2 Score [cardiac failure, hypertension, age, diabetes, stroke (doubled)] [ Time Frame: 1 day ]
CHA2DS2-VASc Score [cardiac failure, hypertension, age >=75 (doubled), diabetes, stroke (doubled), vascular disease, age 65-74 and sex category (female) [ Time Frame: 1 day ]
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 ]
Antithrombotic treatment choice at baseline [ Time Frame: 1 day ]
Transient Ischemic attack (TIA) [ Time Frame: up to 3 years ]
Systemic embolism [ Time Frame: up to 3 years ]
Pulmonary embolism [ Time Frame: up to 3 years ]
composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ]

Change History

Complete list of historical versions of study NCT01468701 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

GLORIA-AF Registry Program - Second and Third Phases

Official Title ^ICMJE

GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)

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 two protocol numbers: 1160.129 for all 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

patients with non-valvular AF

Condition ^ICMJE

Stroke
Atrial Fibrillation

Intervention ^ICMJE

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Huisman MV, Lip GY, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Teutsch C, Zint K, Ackermann D, Clemens A, Bartels DB. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014 Mar;167(3):329-34. doi: 10.1016/j.ahj.2013.12.006. Epub 2013 Dec 19.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

19000

Estimated Completion Date

January 2020

Estimated Primary Completion Date

January 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Age =>18 years at enrollment
Male or female patient (or legally acceptable representative) willing and able to provide written informed consent
Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke.

Other 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 Other exclusion criteria apply

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, Hong Kong, Japan, Korea, Republic of, Lebanon, Mexico, Peru, Russian Federation, Saudi Arabia, Singapore, South Africa, Taiwan, United Arab Emirates, United States, Venezuela

Removed Location Countries

Croatia, Puerto Rico, Turkey

Administrative Information

NCT Number ^ICMJE

NCT01468701

Other Study ID Numbers ^ICMJE

1160.129

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Boehringer Ingelheim

Study Sponsor ^ICMJE

Boehringer Ingelheim

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

PRS Account

Boehringer Ingelheim

Verification Date

March 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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