Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation

NCT03570047

Last updated date
Study Location
Pfizer Japan
Tokyo, , , Japan
Contact
1-800-718-1021

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

Patients must meet all of the following criteria to be eligible for the study:

1. Diagnosed with AF anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.

2. Prescribed one of the index OACs (apixaban, dabigatran, edoxaban, rivaroxaban or warfarin) on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort

3. No use of the any OACs during the baseline period (the 180 days before the index date)

4. Age of 18 years or older on the index date.

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. Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation,
rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the
baseline and post-index period 2. Having a cardiac surgery procedure record during the
baseline period 3. Having a joint replacement procedure record during the baseline period
4. Having a procedure of prosthetic heart valve during the baseline period 5. Having a
diagnosis of venous thromboembolism during the baseline period 6. Female patients with
pregnancy during the follow-up period 7. Patients prescribed "off-label" doses of OACs (per
Japanese package insert of each OAC) or patients treated with OAC but in "off-label" or
"contraindicated" manners.


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Non-valvular Atrial FibrillationSafety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation NCT03570047
  1. Tokyo,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation
Official Title SAFETY AND EFFECTIVENESS EVALUATION OF PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION TREATED WITH OACS: COMPARISON BETWEEN NOACS AND WARFARIN (CER3)
Brief Summary An anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular AF (NVAF) patients. Warfarin, a vitamin K antagonist, is the first oral anticoagulant approved for the treatment for prevention of thromboembolism and it had long been the only oral anticoagulant until the first non-vitamin K antagonist oral anticoagulants (NOACs). However, its safety and effectiveness remains unknown in real-world clinical practice in Japan
Detailed Description An anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular AF (NVAF) patients. Warfarin, a vitamin K antagonist, is the first oral anticoagulant approved for the treatment for prevention of thromboembolism and it had long been the only oral anticoagulant until the first non-vitamin K antagonist oral anticoagulants (NOACs). However, its safety and effectiveness remains unknown in real-world clinical practice in Japan. This study will evaluate the risk of stroke/SE as well as the risk of bleeding in the real world settings in Japan in patients with NVAF who initiated any of OACs (apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin)
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with NVAF who initiated any of oral anti-coagulants
Condition Non-valvular Atrial Fibrillation
Intervention Not Provided
Study Groups/Cohorts Not Provided
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: October 12, 2019)
73989
Original Actual Enrollment
 (submitted: June 15, 2018)
50000
Actual Study Completion Date October 31, 2018
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria

Patients must meet all of the following criteria to be eligible for the study:

  1. Diagnosed with AF anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.
  2. Prescribed one of the index OACs (apixaban, dabigatran, edoxaban, rivaroxaban or warfarin) on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort
  3. No use of the any OACs during the baseline period (the 180 days before the index date)
  4. Age of 18 years or older on the index date.

Exclusion criteria

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

1. Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period 2. Having a cardiac surgery procedure record during the baseline period 3. Having a joint replacement procedure record during the baseline period 4. Having a procedure of prosthetic heart valve during the baseline period 5. Having a diagnosis of venous thromboembolism during the baseline period 6. Female patients with pregnancy during the follow-up period 7. Patients prescribed "off-label" doses of OACs (per Japanese package insert of each OAC) or patients treated with OAC but in "off-label" or "contraindicated" manners.

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Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03570047
Other Study ID Numbers B0661120
CER3 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
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 October 2019