Trial Outcomes & Findings for Adherence to New Oral Anticoagulation Therapy in Turkey (NCT NCT02480920)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

2738 participants

Primary outcome timeframe

10 months

Results posted on

2019-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Study Popülation: Who Received NOAC for More Than 3 Months This multicenter cross-sectional study was conducted between September 2015 and February 2016 in 45 centers encompassing all the geographical regions of Turkey. A total of 3150 patients were evaluated in this study. The 163 patients with a sociocultural level inadequate to fill the questionnaire and the 249 patients who received new oral anticoagulant for less than 3 months were excluded from the study. This study was conducted with the remaining 2738 patients.
Overall Study STARTED	2738
Overall Study COMPLETED	2738
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adherence to New Oral Anticoagulation Therapy in Turkey

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Population n=2738 Participants This multicenter cross-sectional study was consisted of patients who with non-valvular atrial fibrillation (NVAF) receiving Non-vitamin K antagonist oral anticoagulants NOACs), older than 18 years, who were followed up in cardiology clinics, and who received dabigatran (110-150 mg), rivaroxaban (15-20 mg), or apixaban (2.5-5 mg) for the last 3 months with \>30 days of supply due to NVAF. The patients were categorized into 2 groups as adherent patients who had high and medium adherence (Morisky score 6 or more) and non-adherent patients who had low adherence (Morisky score 5 or less).
Age, Continuous	70 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	1623 Participants n=5 Participants
Sex: Female, Male Male	1115 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Study Popülation: Who Received NOAC for More Than 3 Months n=2378 Participants In order to identify the independent predictive variables that could affect the medication adherence of the patients with logistic regression analysis, the patients were categorized into 2 groups as adherent patients who had high and medium adherence (Morisky score 6 or more) and nonadherent patients who had low adherence (Morisky score 5 or less).
Compliance of NOACs in Turkish Population low adherence	1342 Participants
Compliance of NOACs in Turkish Population high and medium adherence	1036 Participants

Adverse Events

Advers Events

Serious events: 687 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Advers Events n=2738 participants at risk The adverse effects, stroke, and any bleeding complication during NOAC treatment. Major bleeding was defined as a hemorrhage leading to a reduction in hemoglobin concentration of 2 g/dL, necessitating the transfusion of 2 or more units of blood, or symptomatic bleeding into a critical area or organ.
Nervous system disorders Stroke	3.7% 100/2738
General disorders Bleeding	21.1% 577/2738
Vascular disorders Systemic Embolism	0.37% 10/2738

Other adverse events

Adverse event data not reported

Additional Information

Volkan Emren

Department of Cardiology, Afyonkarahisar State Hospital, Afyonkarahisar, Turkey

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place