Comparison of Efficacy and Safety Among Dabigatran, Rivaroxaban, and Apixaban in Non-Valvular Atrial Fibrillation
Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
1. The recent development of novel oral anticoagulants (NOACs), including direct thrombin
inhibitor (dabigatran) and factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban),
could potentially overcome many drawbacks of warfarin, and might provide a safer, and
even more effective and convenient alternative approach to warfarin in non-valvular
atrial fibrillation (NVAF), especially in Asians.
2. According to the results of a meta-analysis comparing Asians and non-Asians, NOACs are
preferentially indicated in Asians in terms of both efficacy and safety.
3. There is no randomized controlled trial with sufficient power to directly compare the
efficacy and safety among NOACs in NVAF, not to speak of Asians and Chinese.
4. Indirect comparisons are only based on observation with a lot of limitations such as
heterogeneous background characteristics, difference in study design, and diversity in
time within therapeutic range in control group. The findings from indirect comparisons
are not conclusive but only hypothesis-generating.
5. This investigator-initiated prospective randomized open blinded end-point clinical trial
will directly compare the efficacy and safety among 3 NOACs in patients with NVAF in
Taiwan. We hypothesize that rivaroxaban or apixaban is non-inferior to dabigatran in
terms of the efficacy.
Phase:
Phase 4
Details
Lead Sponsor:
National Cheng-Kung University Hospital
Collaborators:
E-DA Hospital Ministry of Health and Welfare, Taiwan National Cheng-Kung University Hospital Dou-Liou Branch Tainan Municipal Hospital