GLORIA-AF Registry Program (Phase I)

Atrial Fibrillation Clinical Trial

Official title:

GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase I)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428765
• Other study ID #: 1160.114
• Status: Completed
• Phase: N/A
• First received: August 25, 2011
• Last updated: January 21, 2014
• Start date: May 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationCroatia: Agency for Medicinal Product and Medical DevicesEgypt:Germany: Ethics CommissionLebanon:Netherlands:Spain:Turkey: Ministry of HealthUnited Arab. Emirates:
• Study type: Observational

Clinical Trial Summary

This study constitutes Phase I of the Registry Program. The main objective of this study is to characterize the newly diagnosed non-valvular AF patient population at risk for stroke and the selection of antithrombotic treatment for stroke prevention in a real-world setting before dabigatran etexilate is approved for the prevention of strokes and systemic emboli in patients with non-valvular AF in different regions of the world.

Description:

Study Design:

cross-sectional

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1096
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

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

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 oral anticoagulant treatment (vitamin K antagonist) (VKA) in their lifetime;

3. Atrial fibrillation (AF) with a generally reversible cause;

4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (VKAs) is indicated

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
China	1160.114.08017 Boehringer Ingelheim Investigational Site	Beijing
China	1160.114.08018 Boehringer Ingelheim Investigational Site	Beijing
China	1160.114.08019 Boehringer Ingelheim Investigational Site	Beijing
China	1160.114.08020 Boehringer Ingelheim Investigational Site	Beijing
China	1160.114.08023 Boehringer Ingelheim Investigational Site	Beijing
China	1160.114.08024 Boehringer Ingelheim Investigational Site	Beijing
China	1160.114.08025 Boehringer Ingelheim Investigational Site	Beijing
China	1160.114.08007 Boehringer Ingelheim Investigational Site	Changsha
China	1160.114.08021 Boehringer Ingelheim Investigational Site	Dalian
China	1160.114.08004 Boehringer Ingelheim Investigational Site	Ghuangzhou
China	1160.114.08006 Boehringer Ingelheim Investigational Site	Ghuangzhou
China	1160.114.08001 Boehringer Ingelheim Investigational Site	Guangzhou
China	1160.114.08002 Boehringer Ingelheim Investigational Site	Guangzhou
China	1160.114.08005 Boehringer Ingelheim Investigational Site	Guangzhou
China	1160.114.08011 Boehringer Ingelheim Investigational Site	Hangzhou
China	1160.114.08015 Boehringer Ingelheim Investigational Site	Hangzhou
China	1160.114.08026 Boehringer Ingelheim Investigational Site	Nanjing
China	1160.114.08010 Boehringer Ingelheim Investigational Site	Shanghai
China	1160.114.08012 Boehringer Ingelheim Investigational Site	Shanghai
China	1160.114.08014 Boehringer Ingelheim Investigational Site	Shanghai
China	1160.114.08016 Boehringer Ingelheim Investigational Site	Shanghai
China	1160.114.08027 Boehringer Ingelheim Investigational Site	Shanghai
China	1160.114.08028 Boehringer Ingelheim Investigational Site	Shenzhen
China	1160.114.08022 Boehringer Ingelheim Investigational Site	Tianjin
China	1160.114.08008 Boehringer Ingelheim Investigational Site	Wuhan
Croatia	1160.114.04002 Boehringer Ingelheim Investigational Site	Krapinske Toplice
Croatia	1160.114.04001 Boehringer Ingelheim Investigational Site	Opatija
Croatia	1160.114.04003 Boehringer Ingelheim Investigational Site	Zagreb
Croatia	1160.114.04004 Boehringer Ingelheim Investigational Site	Zagreb
Egypt	1160.114.28001 Boehringer Ingelheim Investigational Site	Cairo
Germany	1160.114.490201 Boehringer Ingelheim Investigational Site	Berlin
Germany	1160.114.490216 Boehringer Ingelheim Investigational Site	Berlin
Germany	1160.114.490220 Boehringer Ingelheim Investigational Site	Berlin
Germany	1160.114.490217 Boehringer Ingelheim Investigational Site	Dessau-Roßlau
Germany	1160.114.490214 Boehringer Ingelheim Investigational Site	Dinslaken
Germany	1160.114.490215 Boehringer Ingelheim Investigational Site	Halle
Germany	1160.114.490206 Boehringer Ingelheim Investigational Site	Itzehoe
Germany	1160.114.490209 Boehringer Ingelheim Investigational Site	Kempen
Germany	1160.114.490208 Boehringer Ingelheim Investigational Site	Ludwigsburg
Germany	1160.114.490212 Boehringer Ingelheim Investigational Site	Markkleeberg
Germany	1160.114.490207 Boehringer Ingelheim Investigational Site	Mühldorf
Germany	1160.114.490210 Boehringer Ingelheim Investigational Site	München
Germany	1160.114.490202 Boehringer Ingelheim Investigational Site	Northeim
Germany	1160.114.490204 Boehringer Ingelheim Investigational Site	Nürnberg
Germany	1160.114.490211 Boehringer Ingelheim Investigational Site	Wittenberg
Lebanon	1160.114.07001 Boehringer Ingelheim Investigational Site	Beirut
Netherlands	1160.114.31013 Boehringer Ingelheim Investigational Site	Deventer
Netherlands	1160.114.31008 Boehringer Ingelheim Investigational Site	Enschede
Netherlands	1160.114.31005 Boehringer Ingelheim Investigational Site	Maastricht
Spain	1160.114.34012 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1160.114.34004 Boehringer Ingelheim Investigational Site	Jaén
Spain	1160.114.34010 Boehringer Ingelheim Investigational Site	Madrid
Spain	1160.114.34003 Boehringer Ingelheim Investigational Site	Málaga
Spain	1160.114.34005 Boehringer Ingelheim Investigational Site	Murcia
Spain	1160.114.34013 Boehringer Ingelheim Investigational Site	Sabadell (Barcelona)
Spain	1160.114.34011 Boehringer Ingelheim Investigational Site	Santiago de Compostela
Spain	1160.114.34001 Boehringer Ingelheim Investigational Site	Sevilla
Spain	1160.114.34006 Boehringer Ingelheim Investigational Site	Sevilla
Turkey	1160.114.09004 Boehringer Ingelheim Investigational Site	Adana
Turkey	1160.114.09001 Boehringer Ingelheim Investigational Site	Ankara
Turkey	1160.114.09006 Boehringer Ingelheim Investigational Site	Antalya
Turkey	1160.114.09009 Boehringer Ingelheim Investigational Site	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

China,  Croatia,  Egypt,  Germany,  Lebanon,  Netherlands,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHADS2 Score	CHADS2 score is based on a point system in which 2 points are assigned for a history of stroke or transient ischemic attack and 1 point each is assigned for age equal to or greater more than 75 years, hypertension, diabetes, or clinical heart failure or impaired left ventricular systolic function (generally interpreted as an ejection fraction = 40%).	Baseline	No
Primary	CHA2DS2-VASc Score	The CHA2DS2-VASc risk score is based on a point system in which 2 points are assigned for a history of stroke or TIA, or age =75; and 1 point each is assigned for age 65-74 years, a hypertension, diabetes, cardiac failure, vascular disease and female sex. On the basis of the risk strata defined in previous guidelines, a CHA2DS2-VASc score of 0 corresponds to "low risk", a score of 1 corresponds to "intermediate risk", and a score of 2 or more corresponds to "high risk".	Baseline	No
Primary	HAS-BLED Risk Score	The HAS-BLED score is based on a point system in which 1 point is assigned for hypertension (systolic blood pressure >160 mmHg), 1 point for each of abnormal renal (presence of chronic dialysis or renal transplantation or serum creatinine =200 µmol/L) and liver (chronic hepatic disease or biochemical evidence of significant hepatic derangement) function, 1 point each is assigned for stroke, bleeding (previous bleeding history and/or predisposition to bleeding), labile Internation Normalized Ratios (INRs,unstable/high INRs or poor time in therapeutic range), age >65 years and 1 point each for drugs (such as antiplatelet agents, non-steroidal anti-inflammatory drugs) or alcohol.	Baseline	No
Primary	Antithrombotic Treatment Choice at Baseline		Baseline	No
Primary	Gender		Baseline	No
Primary	Age Group		Baseline	No
Primary	Medical History		Baseline	No
Primary	Concomitant Medication		Baseline	No