ArticleCardiology and therapy2020
Idarucizumab for Emergency Reversal of Anticoagulant Effects of Dabigatran: Interim Results of a Japanese Post-Marketing Surveillance Study.
Article in Cardiology and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02946931 (The Drug Use-results Survey), which is not on this map. Cited by 10 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Drug Use-results Survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan
Who cites it
10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 17 citations in OpenAlex.
- Urgent procedures or surgeries in patients receiving oral anticoagulants: a systematic literature review.Journal of thrombosis and thrombolysis · 2023Pooled it
- Evaluation of Direct Oral Anticoagulant Reversal Agents in Intracranial Hemorrhage: A Systematic Review and Meta-analysis.JAMA network open · 2022Pooled it
- Dabigatran Reversal With Idarucizumab and In-Hospital Mortality in Intracranial Hemorrhage: A Systematic Review of Real-Life Data From Case Reports and Case Series.Frontiers in neurology · 2021Pooled it
- Specific reversal agents for direct oral anticoagulants in neurosurgical emergencies - a systematic review.Research and practice in thrombosis and haemostasis · 2025Review
- Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity: Prespecified Subgroup Analysis of the ANNEXA-4 Study in Japan.Journal of atherosclerosis and thrombosis · 2024Article
- Idarucizumab in dabigatran-treated patients with acute stroke: a review and clinical update.Frontiers in neurology · 2024Review
- Idarucizumab for Emergency Reversal of the Anticoagulant Effects of Dabigatran: Final Results of a Japanese Postmarketing Surveillance Study.Cardiology and therapy · 2023Article
- Effectiveness and Safety of Dabigatran Reversal with Idarucizumab in the Taiwanese Population: A Comparison Based on Eligibility for Inclusion in Clinical Trials.Medicina (Kaunas, Lithuania) · 2023Article
- Standard operating procedure for idarucizumab reversal of dabigatran anticoagulation in ischemic and hemorrhagic stroke.Journal of thrombosis and thrombolysis · 2023Review
- Outcome after intracranial hemorrhage under dabigatran and reversal with idarucizumab versus under vitamin-K-antagonists - the RIC-ICH study.Frontiers in neurology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIdarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran, and it was approved in Japan in September 2016. An all-case post-marketing surveillance is ongoing to collect data in Japanese patients treated with idarucizumab who had serious bleeding (Group A) or required an urgent procedure (Group B).
methodsThe primary endpoint was the incidence of adverse drug reactions (ADRs). The secondary endpoint was the maximum extent of reversal of the anticoagulant effect of dabigatran based on activated partial thromboplastin time (aPTT) within 4 h after idarucizumab administration.
resultsThis interim analysis included 262 patients who received idarucizumab. Eighteen patients (6.9%) experienced ADRs within 4 weeks. The reversal effect of idarucizumab based on aPTT within 4 h after idarucizumab administration was assessed in 30 patients and the median maximum percentage reversal was 100%. In Group A, the median time to bleeding cessation in patients without intracranial bleeding was 3.3 h. In Group B, normal intraoperative hemostasis was reported in 63 patients (72.4%).
conclusionsThe results of this interim analysis suggest that idarucizumab is safe and effective for the reversal of dabigatran in Japanese patients in a real-world setting, and support the continued use of idarucizumab.
trial registrationClinicalTrials.gov identifier, NCT02946931.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.