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

NCT03572972

Last updated date
Study Location
Korea University Hospital
Seoul, , , Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Advanced Information
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
  • Drug: Apixaban
    Treatment for NVAF patients
  • Drug: Dabigatran
    Treatment for NVAF patients
  • Drug: Rivaroxaban
    Treatment for NVAF patients
  • Drug: warfarin
    Treatment for NVAF patients
  • Drug: Antiplatelets
    Treatment for NVAF patients
Study Groups/Cohorts
  • Patients prescribed apixaban
    Intervention: Drug: Apixaban
  • Patients prescribed dabigatran
    Intervention: Drug: Dabigatran
  • Patients prescribed rivaroxaban
    Intervention: Drug: Rivaroxaban
  • Patients prescribed warfarin
    Intervention: Drug: warfarin
  • Patients prescribed antiplatelet
    Intervention: Drug: Antiplatelets
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
 (submitted: February 10, 2020)
64684
Original Estimated Enrollment
 (submitted: June 19, 2018)
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:

  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
Sex/Gender
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2020