N/A
Completed N=201
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Source: ClinicalTrials.gov NCT03790917 ↗Enrolled (actual)
201
Serious AEs
10.5%
Results posted
Jun 2020
Primary outcomePrimary: Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1) — 155; 5; 7; 33 Participants
Summary
A prospective non-interventional single-centre study aimed to evaluate actual adherence of AF patients using the validated adherence Scale.
Primary Study Objective(s) Primary study objective The aim of the present study is to assess adherence to therapy and factors associated with adherence in patients with CV disease complicated by non-valvular atrial fibrillation requiring OAC treatment within the outpatient registry PROFILE (prospective, observational study).
1. Data collection in patients with non-valvular atrial fibrillation requiring OAC treatment included in the registry
2. Evaluation of actual patient adherence to OACs
Secondary Study Objective(s)
1. Evaluation of potential patient adherence to OACs
2. Determination of the most significant factors associated with adherence to OACs in patients with non-valvular AF
3. Validation of new original 5-item Questionnaire
4. Evaluation of doctor's adherence to OAC prescription according to Guidelines (ESC). Management of atrial fibrillation,2016)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1) |
155; 5; 7; 33 | — |
| PRIMARY Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact) |
158; 6; 18; 15 | — |
| SECONDARY Proportion of Potentially Adherent Patients |
161; 28; 12 | — |
| SECONDARY Proportion of OACs Prescribed by Doctors According to Guidelines |
171; 30 | — |
| SECONDARY The Main Reasons for Refusing to Start NOAC Therapy |
14; 6; 5; 2; 2; 2 | — |
| SECONDARY Reasons for Stopping Oral Anticoagulants (Data From Visit 1) |
5; 1; 1 | — |
| SECONDARY Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact) |
7; 6; 2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women above 18 years of age who were included in the PROFILE registry by the start of the observational study
- Presence of written informed consent to participate in the study, fill in the study questionnaires and have personal data analyzed
- Presence of any form of non-valvular atrial fibrillation with CHA2DS2-VASc score of ≥1 or patients with CHA2DS2-VASc score = 0, who are already taking OAK
Exclusion Criteria
- Patients with high bleeding risk, including patients with:
- Congenital or acquired bleeding disorders
- Uncontrolled resistant hypertension
- Exacerbation of gastric and duodenal ulcer
- Vascular retinopathy
- Recent history of intracranial or intracerebral hemorrhage
- Pathology of the brain and spinal cord vessels
- Recent history of brain, spinal cord or eye surgery
- History of bronchiectasis or pulmonary hemorrhage
- A CHA2DS2-VASc score of 0 (OACs are not indicated)
- Pregnancy, lactation
- Planned surgery
- Known hypersensitivity to ingredients of medications used in the study
Data sourced from ClinicalTrials.gov (NCT03790917). 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. Informational only — not medical advice.