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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.
Study Design:
cross-sectional
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
1) Patients newly diagnosed with non-valvular atrial fibrillation at risk for stroke.
Exclusion criteria:
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adult patients with non-valvular atrial fibrillation at risk for stroke
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.114.08017 Boehringer Ingelheim Investigational Site | Beijing | China | ||||
| 1160.114.08018 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24576516 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline |
| Medical History | Baseline |
| Concomitant Medication | Baseline |
| 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 | China |
| 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 | Croatia |
| 1160.114.28001 Boehringer Ingelheim Investigational Site | Cairo | Egypt |
| 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 | 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 | Nuremberg | Germany |
| 1160.114.490211 Boehringer Ingelheim Investigational Site | Wittenberg | Germany |
| 1160.114.07001 Boehringer Ingelheim Investigational Site | Beirut | Lebanon |
| 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 | Netherlands |
| 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 | Seville | Spain |
| 1160.114.34006 Boehringer Ingelheim Investigational Site | Seville | Spain |
| 1160.114.09004 Boehringer Ingelheim Investigational Site | Adana | Turkey (Türkiye) |
| 1160.114.09001 Boehringer Ingelheim Investigational Site | Ankara | Turkey (Türkiye) |
| 1160.114.09006 Boehringer Ingelheim Investigational Site | Antalya | Turkey (Türkiye) |
| 1160.114.09009 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%). | Posted | Number | participants | Baseline |
|
|
| |||||||||||||||||||||||||||||||||||||
| 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". | Posted | Number | participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Antithrombotic Treatment Choice at Baseline | Posted | Number | participants | Baseline |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Gender | Posted | Number | participants | Baseline |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Age Group | Posted | Number | participants | Baseline |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Medical History | Posted | Number | participants | Baseline |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Concomitant Medication | Posted | Number | participants | Baseline |
|
|
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | 0 | 1,063 | 0 | 1,063 |
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Low (Score=0) |
| |||||
| Moderate (Score=1) |
| |||||
| High (Score >=2) |
|
|
| Title | Measurements |
|---|---|
|
| Vitamin K Antagonist (VKA) |
|
| Acetylsalicylic Acid (ASA) |
|
| Antiplatelet agents other than ASA |
|
| Other |
|
| Title | Measurements |
|---|
|
| Male |
|
| Title | Measurements |
|---|
|
| 65 to <75 years |
|
| >= 75 years |
|
| Title | Measurements |
|---|
|
| Coronary artery disease (CAD) |
|
| Congestive heart failure |
|
| History of hypertension |
|
| Diabetes mellitus |
|
| Title | Measurements |
|---|---|
|
| Metabolic and anti-inflammatory therapy |
|