Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea
NCT03572972
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Adult Trials: 18+ Years
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)
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
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea | ||||||
| Official Title | THE REAL WORLD EVIDENCE ON TREATMENT PATTERNS, EFFECTIVENESS, AND SAFETY OF DRUGS FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS IN KOREA | ||||||
| Brief Summary | 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 | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Probability Sample | ||||||
| Study Population | Patients will be selected from Korean Health Insurance Review & Assessment Service (HIRA) database according to the inclusion/exclusion criteria. Only users of oral anticoagulant or antiplatelet treatment for atrial fibrillation from July 1, 2015 to November 30, 2016 will be included in this study. | ||||||
| Condition | Atrial Fibrillation | ||||||
| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status | Completed | ||||||
| Actual Enrollment | 64684 | ||||||
| Original Estimated Enrollment | 1 | ||||||
| Actual Study Completion Date | December 20, 2018 | ||||||
| Actual Primary Completion Date | December 20, 2018 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria | Inclusion criteria:
Exclusion criteria: Patients meeting any of the following criteria will not be included in the study.
| ||||||
| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | Korea, Republic of | ||||||
| Removed Location Countries | Korea, Democratic People's Republic of | ||||||
| Administrative Information | |||||||
| NCT Number | NCT03572972 | ||||||
| Other Study ID Numbers | X9001134 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor | Pfizer | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | February 2020 | ||||||