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PRescriptiOn PattERns Of Oral Anticoagulants

PRescriptiOn PattERns Of Oral Anticoagulants in Non-valvular Atrial Fibrillation: A Single Center Experience From Turkey (PROPER)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02366338
Acronym
PROPER
Enrollment
148
Registered
2015-02-19
Start date
2014-08-31
Completion date
2014-11-30
Last updated
2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief 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.

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.

Interventions

None listed

Sponsors

Muğla Sıtkı Koçman University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Non valbular AF \>18 years

Exclusion criteria

* Not currently receiving anticoagulant

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With at Least One Inappropriate MAI Criterion1 dayAppropriateness of oral anticoagulants was evaluated by adapted versions of the MAI

Participant flow

Participants by arm

ArmCount
Group 1
patients on warfarin therapy
73
Group 2
patients on rivaroxaban therapy
39
Group 3
Patients on dabigatran therapy
36
Total148

Baseline characteristics

CharacteristicGroup 1Group 2Group 3Total
Age, Continuous72 years
STANDARD_DEVIATION 9
69 years
STANDARD_DEVIATION 9
72 years
STANDARD_DEVIATION 8
71 years
STANDARD_DEVIATION 9
Region of Enrollment
Turkey
73 participants39 participants36 participants148 participants
Sex: Female, Male
Female
42 Participants22 Participants20 Participants84 Participants
Sex: Female, Male
Male
31 Participants17 Participants16 Participants64 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 730 / 390 / 36
serious
Total, serious adverse events
0 / 730 / 390 / 36

Outcome results

Primary

Number of Patients With at Least One Inappropriate MAI Criterion

Appropriateness of oral anticoagulants was evaluated by adapted versions of the MAI

Time frame: 1 day

ArmMeasureValue (NUMBER)
Group 1Number of Patients With at Least One Inappropriate MAI Criterion61 participants
Group 2Number of Patients With at Least One Inappropriate MAI Criterion11 participants
Group 3Number of Patients With at Least One Inappropriate MAI Criterion17 participants

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026