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Adherence to New Oral Anticoagulation Therapy in Turkey (NOAC-TR)

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ClinicalTrials.gov Identifier: NCT02480920
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Academy Society, Turkey

Brief 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.

Condition or disease
Atrial Fibrillation

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 Type : Observational
Actual Enrollment : 2734 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Drug Adherence in Patients Taking New Oral Anticoagulation Therapy in Turkey
Study Start Date : July 2015
Primary Completion Date : March 2016
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients under 18 years old
  • Patients refused to sign informed consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480920


Locations
Turkey
Volkan Emren
Afyonkarahi̇sar, Turkey
Sponsors and Collaborators
Cardiovascular Academy Society, Turkey
Investigators
Principal Investigator: Volkan Emren, MD Cardiovascular Academy Society, İzmir, Turkey

Responsible Party: Cardiovascular Academy Society, Turkey
ClinicalTrials.gov Identifier: NCT02480920     History of Changes
Other Study ID Numbers: CASTurkey
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by Cardiovascular Academy Society, Turkey:
Atrial fibrillation Drug Adherence
New Oral Anticoagulants
Drug Adherence

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes