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

Last updated on July 17, 2018

FOR MORE INFORMATION
Study Location
Pfizer Japan
Tokyo, , Japan
Contact
1-800-718-1021
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.

NCT03570047
Pfizer
Active, not recruiting
Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation

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Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation
Safety and Effectiveness Evaluation of Patients With Non-valvular Atrial Fibrillation Treated With OACs: Comparison Between NOACs and Warfarin
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
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)
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Patients with NVAF who initiated any of oral anti-coagulants
Non-valvular Atrial Fibrillation
Not Provided
Not Provided
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
50000
Same as current
September 30, 2018
September 30, 2018   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT03570047
B0661120
Not Provided
Not Provided
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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1-800-718-1021

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