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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Korea
Seoul, , Korea, Republic of
Contact
1-800-718-1021
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

NCT03572972
Pfizer
Active, not recruiting
Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea

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Pfizer Clinical Trials Contact Center

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Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea
The Real World Evidence On Treatment Patterns, Effectiveness, And Safety Of Drugs For Stroke Prevention In Nonvalvular Atrial Fibrillation Patients In Korea
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample
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.
Atrial Fibrillation
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1
Same as current
June 18, 2019
February 18, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT03572972
X9001134
No
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
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2018

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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