Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea

NCT ID: NCT03572972

Last Updated: 2023-04-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64684 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-12-20

Brief Summary

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The primary purpose of this study is to evaluate comparative effectiveness and safety outcomes of therapies to prevent thromboembolic events in patients with nonvalvular atrial fibrillation by using Korean nationwide health claims database.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients prescribed apixaban

Apixaban

Intervention Type DRUG

Treatment for NVAF patients

Patients prescribed dabigatran

Dabigatran

Intervention Type DRUG

Treatment for NVAF patients

Patients prescribed rivaroxaban

Rivaroxaban

Intervention Type DRUG

Treatment for NVAF patients

Patients prescribed warfarin

warfarin

Intervention Type DRUG

Treatment for NVAF patients

Patients prescribed antiplatelet

Antiplatelets

Intervention Type DRUG

Treatment for NVAF patients

Interventions

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Apixaban

Treatment for NVAF patients

Intervention Type DRUG

Dabigatran

Treatment for NVAF patients

Intervention Type DRUG

Rivaroxaban

Treatment for NVAF patients

Intervention Type DRUG

warfarin

Treatment for NVAF patients

Intervention Type DRUG

Antiplatelets

Treatment for NVAF patients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 18 years or older on the index date
2. Patients had ≥1 medical claim for AF (refer to Table 1) before or on the index date with at least one hospitalization or at least two outpatient visits:
3. Patients prescribed aspirin, warfarin, or NOACs during intake period (from July 1, 2015 to November 30, 2016)

Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study.

1. Medical claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date
2. Medical claims indicating a diagnosis code indicative of rheumatic mitral valvular heart disease, mitral valve stenosis during the 12-month baseline period (Valvular AF / Prosthetic heart valves)
3. Medical claims indicating a diagnosis code of VTE (Venous thromboembolism) during the 12-month baseline period
4. Medical claims indicating a diagnosis or procedure code of transient AF, or cardiac surgery during the 12-month baseline period (Thyrotoxicosis, Hypertrophic cardiomyopathy, Elective defibrillation, radiofrequency ablation, or left atrial appendage occlusion)
5. Medical claims indicating a diagnosis code of other conditions during the 12-month baseline period (End-stage chronic kidney disease / Kidney transplant / Dialysis / Pericarditis)
6. For the comparison of "NOAC versus NOAC", and "NOAC versus warfarin", patients with any OACs (apixaban, dabigatran, rivaroxaban, or warfarin) in the pre-index period (from 1 year prior to the day before index date)
7. For the comparison of "NOAC versus aspirin", patients with following medications in the pre-index period (from 1 year prior to the day before index date)

* NOAC user: OACs (apixaban, dabigatran, rivaroxaban, warfarin)
* Aspirin user: none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Korea University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee MY, Han S, Bang OY, On YK, Jang SW, Han S, Ryu J, Park YJ, Kang S, Suh HS, Kim YH. Drug Utilization Pattern of Oral Anticoagulants in Patients with Atrial Fibrillation: A Nationwide Population-Based Study in Korea. Adv Ther. 2022 Jul;39(7):3112-3130. doi: 10.1007/s12325-022-02151-z. Epub 2022 May 7.

Reference Type DERIVED
PMID: 35524839 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=X9001134

To obtain contact information for a study center near you, click here.

Other Identifiers

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X9001134

Identifier Type: -

Identifier Source: org_study_id

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