Atrial FibrillationPROPERNCT02366338
PRescriptiOn PattERns Of Oral Anticoagulants
An observational study of Atrial Fibrillation, run by Muğla Sıtkı Koçman University.
Trial summary
Atrial fibrillation is the major cause of acute ischemic stroke. The risk of stroke was shown to decline by oral anticoagulant therapy. The investigators intended to evaluate appropriate use of anticoagulants in non-valvular AF patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Nov 2014
- How long will I take part?
- 1 Day
- 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: Non-valvular AF patients
Who may be able to join
- Non valbular AF >18 years
Who cannot join
- Not currently receiving anticoagulant
About this study
Official title: PRescriptiOn PattERns Of Oral Anticoagulants in Non-valvular Atrial Fibrillation: A Single Center Experience From Turkey (PROPER)
Atrial fibrillation is the major cause of acute ischemic stroke. The risk of stroke was shown to decline by oral anticoagulant therapy. The investigators intended to evaluate appropriate use of anticoagulants in non-valvular AF patients.
Read the detailed description
Atrial fibrillation, the most common sustained arrhythmia, is the major cause of acute ischemic stroke. The prognosis of ischemic stroke associated with atrial fibrillation (AF) tends to have a worse prognosis for recovery compared with other ischemic stroke subtypes. The risk of stroke was shown to decline to 68% by oral anticoagulant (OAC) therapy.The investigators have evaluated appropriate use of anticoagulants in non-valvular AF patients. Appropriate use of oral anticoagulants was assessed by Medication Appropriateness Index (MAI). The MAI consists of 10 criteias namely, indication, choice, dosage, modalities and practicability of administration, drug-drug interactions, drug-disease interactions, duplication, duration, and cost-effectiveness. The tenth criteria was not evaluated because of limited data regarding cost-effectiveness of the drugs.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With at Least One Inappropriate MAI Criterion
Appropriateness of oral anticoagulants was evaluated by adapted versions of the MAI
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 2014
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
- Prospective
- Enrolment
- 148 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozcan Basaran, Muğla Sıtkı Koçman University
- Investigators
- Ozcan Basaran, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366338
- Sponsor's protocol ID
- PROPER
- Acronym
- PROPER
- Status last verified
- Apr 2015
- First submitted
- 8 Feb 2015
- Last updated
- 21 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRescriptiOn PattERns Of Oral Anticoagulants in Non-valvular Atrial Fibrillation: A Single Center Experience From Turkey (PROPER)
- ClinicalTrials.gov ID
- NCT02366338
- Acronym / sponsor ID
- PROPER / PROPER
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Posted 21 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation is the major cause of acute ischemic stroke. The risk of stroke was shown to decline by oral anticoagulant therapy. The investigators intended to evaluate appropriate use of anticoagulants in non-valvular AF patients.
Detailed description
Atrial fibrillation, the most common sustained arrhythmia, is the major cause of acute ischemic stroke. The prognosis of ischemic stroke associated with atrial fibrillation (AF) tends to have a worse prognosis for recovery compared with other ischemic stroke subtypes. The risk of stroke was shown to decline to 68% by oral anticoagulant (OAC) therapy.The investigators have evaluated appropriate use of anticoagulants in non-valvular AF patients. Appropriate use of oral anticoagulants was assessed by Medication Appropriateness Index (MAI). The MAI consists of 10 criteias namely, indication, choice, dosage, modalities and practicability of administration, drug-drug interactions, drug-disease interactions, duplication, duration, and cost-effectiveness. The tenth criteria was not evaluated because of limited data regarding cost-effectiveness of the drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-valvular AF patients
Key inclusion criteria (1 listed)
- Non valbular AF >18 years
Key exclusion criteria (1 listed)
- Not currently receiving anticoagulant
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
Number of Patients With at Least One Inappropriate MAI Criterion
Time frame: 1 day
Appropriateness of oral anticoagulants was evaluated by adapted versions of the MAI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Ozcan Basaran principal investigator
Muğla Sıtkı Koçman University
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Muğla Sıtkı Koçman University.
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 1 inclusion and 1 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 21 May 2015). 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?
Number of Patients With at Least One Inappropriate MAI Criterion (time frame: 1 day). 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 21 May 2015.