Trials / Completed
CompletedNCT03570047
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 (CER3)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 73,989 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Timeline
- Start date
- 2018-05-08
- Primary completion
- 2018-10-31
- Completion
- 2018-10-31
- First posted
- 2018-06-26
- Last updated
- 2019-11-04
- Results posted
- 2019-11-04
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03570047. Inclusion in this directory is not an endorsement.