Trial reportThrombosis and haemostasis2017
Single-dose ciraparantag safely and completely reverses anticoagulant effects of edoxaban.
Trial report in Thrombosis and haemostasis, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
37 citing papers in PubMed, 1 synthesis or guideline pooled it, 146 citations in OpenAlex.
- The Reversal of Bleeding Caused by New Oral Anticoagulants (NOACs): A Systematic Review and Meta-Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis · 2018Pooled it
- Ciraparantag reverses the anticoagulant activity of apixaban and rivaroxaban in healthy elderly subjects.European heart journal · 2022Trial
- Managing bleeds on anticoagulant therapy: a practical guide for clinicians.European heart journal. Acute cardiovascular care · 2026Review
- Anticoagulation Stewardship Program in the DOAC Era.Journal of clinical medicine · 2026Review
- Direct Oral Anticoagulant Inhibitors: Mode of Action, Clinical Aspects.Handbook of experimental pharmacology · 2026Review
- Review
- Reversal and resumption of anticoagulants in patients with anticoagulant-associated intracerebral hemorrhage.European journal of medical research · 2024Review
- ANMCO/SIMEU consensus document on the use of reversal agents for antithrombotic therapies in patients with ongoing bleeding or at high risk of haemorrhagic events.European heart journal supplements : journal of the European Society of Cardiology · 2024Article
- When and How to Use Reversal Agents for Direct Oral Anticoagulants?Current cardiology reports · 2023Review
- Novel strategies in antithrombotic therapy: targeting thrombosis while preserving hemostasis.Frontiers in cardiovascular medicine · 2023Review
- JCS/JHRS 2020 Guideline on Pharmacotherapy of Cardiac Arrhythmias.Journal of arrhythmia · 2022Article
- Anticoagulant Reversal in Gastrointestinal Bleeding: Review of Treatment Guidelines.Digestive diseases and sciences · 2021Review
- Updated recommendations for the treatment of venous thromboembolism.Blood research · 2021Review
- Direct oral anticoagulants (DOACs) and neck of femur fractures: Standardising the perioperative management and time to surgery.Journal of clinical orthopaedics and trauma · 2021Article
- Factors Affecting the Formation and Treatment of Thrombosis by Natural and Synthetic Compounds.International journal of molecular sciences · 2020Review
- An engineered factor Va prevents bleeding induced by direct-acting oral anticoagulants by different mechanisms.Blood advances · 2020Article
- A review of oral anticoagulants, old and new, in major bleeding and the need for urgent surgery.Trends in cardiovascular medicine · 2020Review
- An Update on the Reversal of Non-Vitamin K Antagonist Oral Anticoagulants.Advances in hematology · 2020Review
- Direct-Acting Oral Anticoagulants and Their Reversal Agents-An Update.Medicines (Basel, Switzerland) · 2019Review
- The Inhibitory Effect of Protamine on Platelets is Attenuated by Heparin without Inducing Thrombocytopenia in Rodents.Marine drugs · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Of the new direct oral anticoagulants, direct factor Xa inhibitors are limited by the absence of a proven reversal agent. We assessed the safety, tolerability and impact on anticoagulation reversal of ciraparantag (PER977) alone and following a 60 mg dose of the FXa inhibitor edoxaban. Escalating, single IV doses of ciraparantag were administered alone and following a 60 mg oral dose of edoxaban in a double-blind, placebo-controlled fashion to healthy subjects. Serial assessments of the pharmacokinetics and pharmacodynamic effects of ciraparantag were performed. Eighty male subjects completed the study. Following edoxaban (60 mg), a single IV dose of ciraparantag (100 to 300 mg) demonstrated full reversal of anticoagulation within 10 minutes and sustained for 24 hours. Fibrin diameter within clots was restored to normal 30 minutes after a single dose of 100 to 300 mg ciraparantag as determined by scanning electron microscopy and change in fibrin diameter quantified by automated image analysis. Potentially related adverse events were periorbital and facial flushing and cool sensation following IV injection of ciraparantag. Renal excretion of ciraparantag metabolite was the main elimination route. There was no evidence of procoagulant activity following ciraparantag as assessed by D-dimer, prothrombin fragments 1.2, and tissue factor pathway inhibitor levels. In conclusion, ciraparantag in healthy subjects is safe and well tolerated with minor, non-dose limiting adverse events. Baseline haemostasis was restored from the anticoagulated state with doses of 100 to 300 mg ciraparantag within 10-30 minutes of administration and sustained for at least 24 hours.
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What OpenQuestion holds
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.