GLORIA-AF Registry Program (Phase I)
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT01428765
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Study Design:
cross-sectional
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1096
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CHADS2 Score Baseline 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%).
CHA2DS2-VASc Score Baseline 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".
HAS-BLED Risk Score Baseline 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.
Antithrombotic Treatment Choice at Baseline Baseline Gender Baseline Age Group Baseline Medical History Baseline Concomitant Medication Baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (62)
1160.114.04001 Boehringer Ingelheim Investigational Site
🇭🇷Opatija, Croatia
1160.114.31008 Boehringer Ingelheim Investigational Site
🇳🇱Enschede, Netherlands
1160.114.08017 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1160.114.08023 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1160.114.490215 Boehringer Ingelheim Investigational Site
🇩🇪Halle, Germany
1160.114.490220 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1160.114.08025 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1160.114.490217 Boehringer Ingelheim Investigational Site
🇩🇪Dessau-Roßlau, Germany
1160.114.490209 Boehringer Ingelheim Investigational Site
🇩🇪Kempen, Germany
1160.114.490208 Boehringer Ingelheim Investigational Site
🇩🇪Ludwigsburg, Germany
1160.114.34001 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1160.114.31013 Boehringer Ingelheim Investigational Site
🇳🇱Deventer, Netherlands
1160.114.31005 Boehringer Ingelheim Investigational Site
🇳🇱Maastricht, Netherlands
1160.114.08024 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1160.114.09009 Boehringer Ingelheim Investigational Site
🇹🇷Istanbul, Turkey
1160.114.490211 Boehringer Ingelheim Investigational Site
🇩🇪Wittenberg, Germany
1160.114.07001 Boehringer Ingelheim Investigational Site
🇱🇧Beirut, Lebanon
1160.114.34013 Boehringer Ingelheim Investigational Site
🇪🇸Sabadell (Barcelona), Spain
1160.114.490206 Boehringer Ingelheim Investigational Site
🇩🇪Itzehoe, Germany
1160.114.490214 Boehringer Ingelheim Investigational Site
🇩🇪Dinslaken, Germany
1160.114.34011 Boehringer Ingelheim Investigational Site
🇪🇸Santiago de Compostela, Spain
1160.114.34006 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1160.114.490216 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1160.114.09006 Boehringer Ingelheim Investigational Site
🇹🇷Antalya, Turkey
1160.114.490204 Boehringer Ingelheim Investigational Site
🇩🇪Nürnberg, Germany
1160.114.34012 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1160.114.34010 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
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
1160.114.34004 Boehringer Ingelheim Investigational Site
🇪🇸Jaén, Spain
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
1160.114.08018 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1160.114.08019 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, 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
1160.114.08010 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, China
1160.114.490202 Boehringer Ingelheim Investigational Site
🇩🇪Northeim, Germany
1160.114.34003 Boehringer Ingelheim Investigational Site
🇪🇸Málaga, Spain
1160.114.28001 Boehringer Ingelheim Investigational Site
🇪🇬Cairo, Egypt
1160.114.490201 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1160.114.09001 Boehringer Ingelheim Investigational Site
🇹🇷Ankara, Turkey
1160.114.09004 Boehringer Ingelheim Investigational Site
🇹🇷Adana, Turkey
1160.114.34005 Boehringer Ingelheim Investigational Site
🇪🇸Murcia, Spain
1160.114.04002 Boehringer Ingelheim Investigational Site
🇭🇷Krapinske Toplice, Croatia
1160.114.04003 Boehringer Ingelheim Investigational Site
🇭🇷Zagreb, Croatia
1160.114.04004 Boehringer Ingelheim Investigational Site
🇭🇷Zagreb, Croatia
1160.114.08020 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1160.114.08026 Boehringer Ingelheim Investigational Site
🇨🇳Nanjing, China