N/A
N=73,989
Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation
Non-valvular Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03570047 ↗Enrolled (actual)
73,989
Serious AEs
—
Results posted
Nov 2019
Primary outcome: Primary: Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date — 3.2; 1.67; 2.08; 1.79 Events Per 100 Participant-Years — p=<0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date |
3.2; 1.67; 2.08; 1.79; 2 | <0.0001 sig |
| PRIMARY Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date |
3.13; 1.79; 1.72; 1.82; 1.91 | <0.0001 sig |
| PRIMARY Event Rate Per 100 Participant-Years For First Occurrence of Any Bleeding Event After Index Date |
22.11; 15.97; 15.9; 16.07; 20.34 | 0.0127 sig |
| SECONDARY Event Rate Per 100 Participant-Years For First Occurrence of Ischemic Stroke After Index Date |
2.4; 1.2; 1.76; 1.41; 1.54 | — |
| SECONDARY Event Rate Per 100 Participant-Years For First Occurrence of Hemorrhagic Stroke After Index Date |
0.72; 0.43; 0.25; 0.36; 0.43 | — |
| SECONDARY Event Rate Per 100 Participant-Years For First Occurrence of Systemic Embolism Events After Index Date |
0.11; 0.04; 0.08; 0.04; 0.05 | — |
| SECONDARY Event Rate Per 100 Participant-Years For First Occurrence of Major Gastrointestinal Bleeding Events After Index Date |
1.02; 0.61; 0.77; 0.74; 0.73 | — |
| SECONDARY Event Rate Per 100 Participant-Years For First Occurrence of Any Gastrointestinal Bleeding Event After Index Date |
5.98; 4.11; 4.75; 4.07; 5.42 | — |
| SECONDARY Event Rate Per 100 Participant-Years For First Occurrence of Major Intracranial Hemorrhage Events After Index Date |
1.22; 0.57; 0.43; 0.5; 0.62 | — |
| SECONDARY Event Rate Per 100 Participant-Years For First Occurrence of Any Intracranial Hemorrhage Event After Index Date |
4.16; 2.93; 2.43; 2.66; 3.65 | — |
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
Eligibility Criteria
Inclusion criteria
Patients must meet all of the following criteria to be eligible for the study:
- 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.
- 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
- No use of the any OACs during the baseline period (the 180 days before the index date)
- 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:
- 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.
-
Data sourced from ClinicalTrials.gov (NCT03570047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.