Clinical trial NCT03570047: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation
Keywords: Non-valvular atrial fibrillation, NVAF
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 73989
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with NVAF who initiated any of oral anti-coagulants

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)

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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Primary outcomes:
measure: Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date
timeFrame: During the observation period of approximately 7 years
measure: Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date
timeFrame: During the observation period of approximately 7 years
measure: Event Rate Per 100 Participant-Years For First Occurrence of Any Bleeding Event After Index Date
timeFrame: During the observation period of approximately 7 years
Secondary outcomes:
measure: Event Rate Per 100 Participant-Years For First Occurrence of Ischemic Stroke After Index Date
timeFrame: During the observation period of approximately 7 years
measure: Event Rate Per 100 Participant-Years For First Occurrence of Hemorrhagic Stroke After Index Date
timeFrame: During the observation period of approximately 7 years
measure: Event Rate Per 100 Participant-Years For First Occurrence of Systemic Embolism Events After Index Date
timeFrame: During the observation period of approximately 7 years
measure: Event Rate Per 100 Participant-Years For First Occurrence of Major Gastrointestinal Bleeding Events After Index Date
timeFrame: During the observation period of approximately 7 years
measure: Event Rate Per 100 Participant-Years For First Occurrence of Any Gastrointestinal Bleeding Event After Index Date
timeFrame: During the observation period of approximately 7 years
measure: Event Rate Per 100 Participant-Years For First Occurrence of Major Intracranial Hemorrhage Events After Index Date
timeFrame: During the observation period of approximately 7 years
measure: Event Rate Per 100 Participant-Years For First Occurrence of Any Intracranial Hemorrhage Event After Index Date
timeFrame: During the observation period of approximately 7 years
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Japan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: