GLORIA-AF Registry Program (Phase I)

NCT01428765 | Completed Results

• 1 other identifier: 1160.114
• Study Type: observational
• Target: 1,096
• Locations: 8 countries
• Sites: 62

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• Antithrombotic Treatment Choice at Baseline

  Baseline

• Gender

  Baseline

• Age Group

  Baseline

• Medical History

  Baseline

• Concomitant Medication

  Baseline

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

adult patients with non-valvular atrial fibrillation at risk for stroke

You may qualify if:

• \) Patients newly diagnosed with non-valvular atrial fibrillation 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 oral anticoagulant treatment (vitamin K antagonist) (VKA) in their lifetime;
• Atrial fibrillation (AF) with a generally reversible cause;
• Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (VKAs) is indicated

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (62)

1160.114.08017 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1160.114.08018 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1160.114.08019 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1160.114.08020 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1160.114.08023 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1160.114.08024 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1160.114.08025 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1160.114.08007 Boehringer Ingelheim Investigational Site

Changsha, China

Location

1160.114.08021 Boehringer Ingelheim Investigational Site

Dalian, China

Location

1160.114.08004 Boehringer Ingelheim Investigational Site

Ghuangzhou, China

Location

1160.114.08006 Boehringer Ingelheim Investigational Site

Ghuangzhou, China

Location

1160.114.08001 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1160.114.08002 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1160.114.08005 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1160.114.08011 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

1160.114.08015 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

1160.114.08026 Boehringer Ingelheim Investigational Site

Nanjing, China

Location

1160.114.08010 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.114.08012 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.114.08014 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.114.08016 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.114.08027 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.114.08028 Boehringer Ingelheim Investigational Site

Shenzhen, China

Location

1160.114.08022 Boehringer Ingelheim Investigational Site

Tianjin, China

Location

1160.114.08008 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

1160.114.04002 Boehringer Ingelheim Investigational Site

Krapinske Toplice, Croatia

Location

1160.114.04001 Boehringer Ingelheim Investigational Site

Opatija, Croatia

Location

1160.114.04003 Boehringer Ingelheim Investigational Site

Zagreb, Croatia

Location

1160.114.04004 Boehringer Ingelheim Investigational Site

Zagreb, Croatia

Location

1160.114.28001 Boehringer Ingelheim Investigational Site

Cairo, Egypt

Location

1160.114.490201 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1160.114.490216 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1160.114.490220 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1160.114.490217 Boehringer Ingelheim Investigational Site

Dessau, Germany

Location

1160.114.490214 Boehringer Ingelheim Investigational Site

Dinslaken, Germany

Location

1160.114.490215 Boehringer Ingelheim Investigational Site

Halle, Germany

Location

1160.114.490206 Boehringer Ingelheim Investigational Site

Itzehoe, Germany

Location

1160.114.490209 Boehringer Ingelheim Investigational Site

Kempen, Germany

Location

1160.114.490208 Boehringer Ingelheim Investigational Site

Ludwigsburg, Germany

Location

1160.114.490212 Boehringer Ingelheim Investigational Site

Markkleeberg, Germany

Location

1160.114.490207 Boehringer Ingelheim Investigational Site

Mühldorf, Germany

Location

1160.114.490210 Boehringer Ingelheim Investigational Site

München, Germany

Location

1160.114.490202 Boehringer Ingelheim Investigational Site

Northeim, Germany

Location

1160.114.490204 Boehringer Ingelheim Investigational Site

Nuremberg, Germany

Location

1160.114.490211 Boehringer Ingelheim Investigational Site

Wittenberg, Germany

Location

1160.114.07001 Boehringer Ingelheim Investigational Site

Beirut, Lebanon

Location

1160.114.31013 Boehringer Ingelheim Investigational Site

Deventer, Netherlands

Location

1160.114.31008 Boehringer Ingelheim Investigational Site

Enschede, Netherlands

Location

1160.114.31005 Boehringer Ingelheim Investigational Site

Maastricht, Netherlands

Location

1160.114.34012 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.114.34004 Boehringer Ingelheim Investigational Site

Jaén, Spain

Location

1160.114.34010 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.114.34003 Boehringer Ingelheim Investigational Site

Málaga, Spain

Location

1160.114.34005 Boehringer Ingelheim Investigational Site

Murcia, Spain

Location

1160.114.34013 Boehringer Ingelheim Investigational Site

Sabadell (Barcelona), Spain

Location

1160.114.34011 Boehringer Ingelheim Investigational Site

Santiago de Compostela, Spain

Location

1160.114.34001 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1160.114.34006 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1160.114.09004 Boehringer Ingelheim Investigational Site

Adana, Turkey (Türkiye)

Location

1160.114.09001 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

1160.114.09006 Boehringer Ingelheim Investigational Site

Antalya, Turkey (Türkiye)

Location

1160.114.09009 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 24576516 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: September 5, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 5, 2014
• Results First Posted: March 5, 2014

Record last verified: 2014-01

Locations

CR (4); TU (4); CN (25); EG (1); LE (1); ES (9); DE (15); NL (3)