An observational study in Atrial Fibrillation, sponsored by Cardiovascular Academy Society, Turkey. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-09.
Sponsored by Cardiovascular Academy Society, Turkey · Observational
This study will compose a national database of drug adherence and investigate the factors that affect drug adherence in patients taking new oral anticoagulation therapy in Turkish Population.
NOACs have several clinical and pharmacological advantages over warfarin however suboptimal adherence is one of the most common causes of failure to respond to medications and outcomes.
This observational multicenter, retrospective study, will compose a national database of drug adherence and investigate the factors that affect drug adherence in patients taking new oral anticoagulation therapy in Turkey.
Social support and adherence to therapy factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires.
Non-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 2,738 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Cardiovascular Academy Society, Turkey is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Compliance of NOACs in Turkish Population
Factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires. Non-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors. The validity of the Morisky Adherence Scale had already been demonstrated with regard to medication adherence in patients receiving vitamin K antagonists. An extended 8-item Morisky scale was used instead of the original 4-item Morisky scale in order to better identify the situations and the conditions that could affect medication adherence and to better assess the psychometric features.The reliability and the validity of the 8-item Morisky Adherence Scale translated into Turkish had been demonstrated in Turkish population by previous studies.
Time frame: 10 months
| Milestone | Study Popülation: Who Received NOAC for More Than 3 Months |
|---|---|
| Started | 2738 |
| Completed | 2738 |
| Not completed | 0 |
Factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires. Non-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors. The validity of the Morisky Adherence Scale had already been demonstrated with regard to medication adherence in patients receiving vitamin K antagonists. An extended 8-item Morisky scale was used instead of the original 4-item Morisky scale in order to better identify the situations and the conditions that could affect medication adherence and to better assess the psychometric features.The reliability and the validity of the 8-item Morisky Adherence Scale translated into Turkish had been demonstrated in Turkish population by previous studies.
| Participants | Study Popülation: Who Received NOAC for More Than 3 Months |
|---|---|
| low adherence | 1342 |
| high and medium adherence | 1036 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Advers Events | — | 687/2,738 (25.1%) | 0/2,738 (0%) |
| Event | Advers Events |
|---|---|
| BleedingGeneral disorders | 577/2738 |
| StrokeNervous system disorders | 100/2738 |
| Systemic EmbolismVascular disorders | 10/2738 |
| Age, Continuous(years) | Study Population |
|---|---|
| Mean | 70 ± 10 |
| Sex: Female, Male(Participants) | Study Population |
|---|---|
| Female | 1623 |
| Male | 1115 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Cardiovascular Academy Society, Turkey