Atrial Fibrillation
Conditions
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
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China, Croatia, Egypt, Germany, Lebanon, Netherlands, Spain, Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients | 1,063 |
| Total | 1,063 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 486 Participants |
| Sex: Female, Male Male | 577 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,063 |
| serious Total, serious adverse events | 0 / 1,063 |
Outcome results
Primary
Age Group
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Age Group | <65 years | 382 participants |
| All Patients | Age Group | 65 to <75 years | 314 participants |
| All Patients | Age Group | >= 75 years | 367 participants |
Primary
Antithrombotic Treatment Choice at Baseline
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Antithrombotic Treatment Choice at Baseline | None | 215 participants |
| All Patients | Antithrombotic Treatment Choice at Baseline | Vitamin K Antagonist (VKA) | 349 participants |
| All Patients | Antithrombotic Treatment Choice at Baseline | Acetylsalicylic Acid (ASA) | 443 participants |
| All Patients | Antithrombotic Treatment Choice at Baseline | Antiplatelet agents other than ASA | 36 participants |
| All Patients | Antithrombotic Treatment Choice at Baseline | Other | 20 participants |
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.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | CHA2DS2-VASc Score | Low (Score=0) | 0 participants |
| All Patients | CHA2DS2-VASc Score | Moderate (Score=1) | 226 participants |
| All Patients | CHA2DS2-VASc Score | High (Score >=2) | 837 participants |
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%).
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | CHADS2 Score | Low (Score=0) | 102 participants |
| All Patients | CHADS2 Score | Moderate (Score=1) | 386 participants |
| All Patients | CHADS2 Score | High (Score >=2) | 575 participants |
Primary
Concomitant Medication
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Concomitant Medication | Antihypertensive/heart failure and antiarrhythmic | 739 participants |
| All Patients | Concomitant Medication | Metabolic and anti-inflammatory therapy | 395 participants |
Primary
Gender
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Gender | Female | 486 participants |
| All Patients | Gender | Male | 577 participants |
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.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | HAS-BLED Risk Score | Low (Score <3) | 860 participants |
| All Patients | HAS-BLED Risk Score | High (Score >=3) | 121 participants |
| All Patients | HAS-BLED Risk Score | Missing | 82 participants |
Primary
Medical History
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Medical History | Previous stroke | 110 participants |
| All Patients | Medical History | Coronary artery disease (CAD) | 256 participants |
| All Patients | Medical History | Congestive heart failure | 256 participants |
| All Patients | Medical History | History of hypertension | 795 participants |
| All Patients | Medical History | Diabetes mellitus | 240 participants |