N/A
N=500
This Study Observes the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Elderly Patients With a Heart Rhythm Disorder in Spain
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03993119 ↗Enrolled (actual)
500
Serious AEs
1.9%
Results posted
Sep 2021
Primary outcome: Primary: Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex — 115; 77; 30; 46 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Non-vitamin K antagonist oral anticoagulant (Drug)
- Age
- Older Adult · 75+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex |
115; 77; 30; 46; 72; 94 | — |
| PRIMARY Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Sex |
2.43; 2.22 | — |
| PRIMARY Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical) |
93; 59; 40; 34; 23; 19 | — |
| PRIMARY Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Patient's Age (Categorical) |
2.33; 2.32; 2.32 | — |
| PRIMARY Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure |
129; 63; 54; 22; 96; 70 | — |
| PRIMARY Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to a Prior Diagnosis of Heart Failure |
2.27; 2.41 | — |
| PRIMARY Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease |
156; 35; 63; 13; 142; 21 | — |
| PRIMARY Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Coronary Artery Disease |
2.38; 2.04 | — |
| PRIMARY Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes |
135; 57; 51; 25; 113; 53 | — |
| PRIMARY Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Diabetes |
2.39; 2.17 | — |
| PRIMARY Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease |
166; 26; 64; 12; 130; 36 | — |
| PRIMARY Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Chronic Kidney Disease |
2.34; 2.25 | — |
| SECONDARY Serum Creatinine Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
1.00; 1.05; 1.15; 1.14 | — |
| SECONDARY Creatinine Clearance From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
63.50; 55.42; 54.45; 53.04; 62.72; 54.59 | — |
| SECONDARY Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
0; 0; 0; 0; 0; 3 | — |
| SECONDARY Aspartate Aminotransferase (AST) Concentration From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
24.13; 21.60; 25.57; 20.81 | — |
| SECONDARY Alanine Aminotransferase (ALT) From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
22.38; 18.28; 21.52; 20.15 | — |
| SECONDARY Bilirubin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
0.83; 0.79; 0.74; 0.75 | — |
| SECONDARY Haemoglobin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
13.23; 13.37; 12.99; 13.17 | — |
| SECONDARY Platelet Levels From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
203.37; 222.07; 215.59; 189.45 | — |
| SECONDARY Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type |
132; 44; 72; 32; 27; 19 | — |
| SECONDARY Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Years Since NVAF Diagnosis According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
4.78; 5.85; 6.01; 5.63; 6.30; 7.95 | — |
| SECONDARY Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of NVAF Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
32; 11; 31; 12; 21; 3 | — |
| SECONDARY Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type |
47; 25; 52; 17; 83; 30 | — |
| SECONDARY Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
171; 70; 151; 57; 16; 6 | — |
| SECONDARY Number of Patients in Each Category of Coronary Interventions According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
19; 9; 14; 4; 3; 2 | — |
| SECONDARY Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
129; 54; 96; 37; 63; 22 | — |
| SECONDARY Clinical Risk Factors: Number of Heart Failure Patients in Each Category of New York Heart Association (NYHA) Classification According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
2; 0; 3; 0; 39; 12 | — |
| SECONDARY Clinical Risk Factors: Left Ventricular Ejection Fraction According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
59.47; 59.43; 58.85; 57.91 | — |
| SECONDARY Age-adjusted Charlson Comorbidity Index Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
5.26; 5.39; 5.99; 6.27 | — |
| SECONDARY Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
176; 65; 147; 55; 16; 11 | — |
| SECONDARY Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
153; 53; 120; 48; 39; 23 | — |
| SECONDARY Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type |
187; 73; 161; 64; 4; 0 | — |
| SECONDARY Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type |
0.29; 0.54; 0.49; 0.36; 0.05; 0.19 | — |
| SECONDARY Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
177; 68; 120; 56; 14; 8 | — |
| SECONDARY Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
0.10; 0.12; 0.48; 0.28; 0.02; 0.03 | — |
| SECONDARY CHA2DS2-VASc Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
4.05; 4.43; 4.63; 4.32 | — |
| SECONDARY Number of Patients on Each Category of CHA2DS2-VASc Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY HAS-BLED Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
1.99; 1.64; 2.01; 2.06 | — |
| SECONDARY Number of Patients in Each Category of HAS-BLED Score According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
0; 0; 0; 0; 147; 64 | — |
| SECONDARY Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type |
0; 0; 0; 0; 192; 76 | — |
| SECONDARY Number of Patients in Each Category of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation |
26; 187; 13; 274 | — |
| SECONDARY Number of Patients Treated Previously With the VKA Acenocoumarol and Number of Patients Treated Previously With the VKA Warfarin According to Duration Since the First NOAC Initiation |
13; 263; 0; 12 | — |
| SECONDARY Duration of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation |
3.65; 3.88; 3.35; 3.65; 3.87 | — |
| SECONDARY Duration Since Non-valvular Atrial Fibrillation (NVAF) Diagnosis Until First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation According to Duration Since the First NOAC Initiation |
1.62; 3.27; 3.71; 4.84; 0.58; 0.99 | — |
| SECONDARY First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation |
23; 174; 2; 81; 9; 143 | — |
| SECONDARY Number of Patients Who Changed (Increased and Decreased) and Did Not Change the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation |
39; 427; 0; 8; 0; 26 | — |
| SECONDARY First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation |
0.01; 1.60; 0.30; 2.38 | — |
| SECONDARY Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation |
0; 1; 0; 15; 0; 7 | — |
| SECONDARY Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation |
2; 24; 0; 8 | — |
| SECONDARY Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation |
0.03; 0.10 | — |
| SECONDARY Number of Patients in Each Category of Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation |
38; 419; 1; 36; 0; 6 | — |
| SECONDARY Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation |
0; 3; 0; 9; 0; 2 | — |
| SECONDARY Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation |
0; 1; 0; 17; 0; 7 | — |
| SECONDARY Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation |
0; 8; 0; 5; 1; 21 | — |
| SECONDARY Number of Patients Who Changed (Increased or Decreased) and Did Not Change the Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation |
1; 40; 0; 1; 0; 1 | — |
| SECONDARY Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation |
0.49 | — |
| SECONDARY Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation |
0; 2; 0; 4 | — |
| SECONDARY Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation |
0; 2; 0; 0 | — |
| SECONDARY Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation |
1; 1; 4; 0; 1; 0 | — |
| SECONDARY Number of Patients Who Changed (Increased and Decreased) and Did Not Change the Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation |
6; 0; 0 | — |
| SECONDARY Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation |
— | — |
| SECONDARY Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation |
— | — |
| SECONDARY Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation |
— | — |
| SECONDARY Duration (in Years) in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation |
0.29; 2.45; 0.29; 2.39; 0.29; 2.54 | — |
| SECONDARY Number of Patients in Each Category of Total Time in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation |
39; 149; 0; 87; 0; 74 | — |
| SECONDARY Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation |
35; 314; 4; 124; 1; 43 | — |
| SECONDARY Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation |
38; 444; 0; 9; 1; 11 | — |
| SECONDARY Time in Treatment With Antiplatelet Agents (in Years) According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation |
5.82; 5.98 | — |
| SECONDARY Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
11; 6; 8; 0; 24; 15 | — |
| SECONDARY Number of Patients in Each Category Clinical Frailty Scale at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
159; 55; 116; 52; 33; 21 | — |
| SECONDARY Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Usage at the Time of First NOAC Initiation According to Current NOAC Type |
138; 61; 135; 54; 52; 14 | — |
Summary
This is an observational, multicenter and cross-sectional study in Non-valvular atrial fibrillation (NVAF) elderly patients currently on Non-vitamin K antagonist oral anticoagulant (NOAC) treatment for their stroke prevention.
Eligibility Criteria
Inclusion Criteria
- Patients are willing and provide written informed consent prior to participate in this study
- Patients ≥ 75 years-old at the time of the study visit.
- Patients with a diagnosis of non-valvular atrial fibrillation (NVAF).
- Patients who are being treated with NOAC treatment according to the indication approved in the Summary of Product Characteristics (SmPC).
- Patients who have started the NOAC treatment at least 3 months prior to the study visit.
Exclusion Criteria
Patients will be excluded from participating in this study if the following criterion is met:
- Current participation in any clinical trial of a drug or device.
- Patients who have any contraindication for NOAC treatment, according to the SmPC.
Data sourced from ClinicalTrials.gov (NCT03993119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.