Atrial FibrillationNOAC-TRNCT02480920
Adherence to New Oral Anticoagulation Therapy in Turkey
An observational study of Atrial Fibrillation, run by Cardiovascular Academy Society, Turkey at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 2,738 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2015to Apr 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation
Who may be able to join
- Patients >18 years old
- Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation
- Patients signed patient informed sheet and informed consent form
Who cannot join
- Patients under 18 years old
- Patients refused to sign informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Adherence in Patients Taking New Oral Anticoagulation Therapy in Turkey
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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation Drug Adherence, New Oral Anticoagulants, Drug Adherence
- Medical subject headings
- Atrial Fibrillation, Medication Adherence
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,738 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Academy Society, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Volkan Emren, MD, Principal investigator, Cardiovascular Academy Society, İzmir, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480920
- Sponsor's protocol ID
- NOAC-TR
- Acronym
- NOAC-TR
- Status last verified
- Apr 2019
- First submitted
- 19 Jun 2015
- Last updated
- 9 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Adherence in Patients Taking New Oral Anticoagulation Therapy in Turkey
- ClinicalTrials.gov ID
- NCT02480920
- Acronym / sponsor ID
- NOAC-TR / NOAC-TR
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation Drug Adherence, New Oral Anticoagulants, Drug Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,738 participants (actual)
- Lead sponsor
- Cardiovascular Academy Society, TurkeyUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Posted 31 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation
Key inclusion criteria (3 listed)
- Patients >18 years old
- Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation
- Patients signed patient informed sheet and informed consent form
Key exclusion criteria (2 listed)
- Patients under 18 years old
- Patients refused to sign informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compliance of NOACs in Turkish Population
Time frame: 10 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volkan Emren, MD principal investigator
Cardiovascular Academy Society, İzmir, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Cardiovascular Academy Society, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance of NOACs in Turkish Population (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.