Trial reportBlood advances2020
A phase 2 PK/PD study of andexanet alfa for reversal of rivaroxaban and edoxaban anticoagulation in healthy volunteers.
Trial report in Blood advances, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 21 papers.
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.
A Randomized, Double-Blind, Vehicle-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect fXa Inhibitors in Healthy Volunteers
A Randomized, Double-Blind, Vehicle-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect fXa Inhibitors in Healthy Volunteers
Who cites it
21 citing papers in PubMed, 39 citations in OpenAlex.
- Comparing Hemostatic Efficacy of Four-factor Prothrombin Complex Concentrate with Andexanet Alfa in an Apixaban-treated Polytrauma Male Porcine Model.Anesthesiology · 2026Article
- TFPIα inhibition by andexanet alfa is partially restored by protein S and factor V-short.Blood advances · 2026Article
- Emergency reversal of Rivaroxaban with Andexanet alfa in a child with hemorrhagic brain metastasis from Wilms tumor.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2026Article
- Excessive Apixaban Concentrations in a Bleeding Patient Treated With Pharmacological Reversal and Extracorporal Removal-A Case Report.Pharmacology research & perspectives · 2026Article
- JCS/JHRS 2024 Guideline Focused Update on Management of Cardiac Arrhythmias.Journal of arrhythmia · 2025Article
- Andexanet alfa for reversal of intracerebral haemorrhage resulting in ST-segment myocardial infarction: a case report.European heart journal. Case reports · 2025Article
- Andexanet Alfa-Associated Heparin Resistance in Cardiac Surgery: Mechanism and In Vitro Perspectives.Arteriosclerosis, thrombosis, and vascular biology · 2025Article
- Rapid Determination of Xa Inhibitor Activity in Blood Using a Microfluidic Device that Measures Platelet Deposition and Fibrin Generation Under Flow.TH open : companion journal to thrombosis and haemostasis · 2025Article
- The Efficacy of Andexanet Alfa for the Reversal of Factor Xa Inhibitors Is Not Influenced by Hemodilution with Different Volume Expanders.Journal of clinical medicine · 2024Article
- Monitoring the efficiency of reversal on anti-Xa direct oral anticoagulants using point-of-care viscoelastic testing.Thrombosis journal · 2024Article
- Improving Patient Safety Through Proper Ordering and Administration of Andexanet Alfa.Mayo Clinic proceedings. Innovations, quality & outcomes · 2024Article
- Andexanet alfa therapy showed No increased rate of thromboembolic events in spontaneous intracranial hemorrhage patients: A multicenter electronic health record study.World neurosurgery: X · 2024Article
- Rapid Detection of Apixaban by a ROTEM-Based Approach and Reversibility with Andexanet Alfa or DOAC-Stop.TH open : companion journal to thrombosis and haemostasis · 2022Article
- Andexanet Alfa for Specific Anticoagulation Reversal in Patients with Acute Bleeding during Treatment with Edoxaban.Thrombosis and haemostasis · 2022Article
- [Management of bleeding in patients on antithrombotic therapy].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2021Review
- Measuring residual anti-Xa activity of direct factor Xa inhibitors after reversal with andexanet alfa.International journal of laboratory hematology · 2021Article
- Recanalisation therapies for acute ischaemic stroke in patients on direct oral anticoagulants.Journal of neurology, neurosurgery, and psychiatry · 2021Review
- Andexanet versus prothrombin complex concentrates: Differences in reversal of factor Xa inhibitors in in vitro thrombin generation.Research and practice in thrombosis and haemostasis · 2020Article
- A Review of the Incidence Diagnosis and Treatment of Spontaneous Hemorrhage in Patients Treated with Direct Oral Anticoagulants.Journal of clinical medicine · 2020Review
- Pharmacokinetics of anticoagulant edoxaban in overdose in a Japanese patient transported to hospital.Journal of pharmaceutical health care and sciences · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
As with any anticoagulant, factor Xa (FXa) inhibitors are associated with a risk of major bleeding. Andexanet alfa is a recombinant modified human FXa lacking enzymatic activity, developed for reversal of FXa inhibitor-induced anticoagulation. In two phase 2, randomized, double-blind, placebo-controlled, single-center studies, different regimens of andexanet alfa were administered to healthy volunteers after therapeutic anticoagulation with rivaroxaban or edoxaban, and multiple anticoagulation reversal and safety end points were evaluated. Andexanet alfa rapidly and effectively reversed anticoagulation with both rivaroxaban and edoxaban. Within 2 minutes after bolus, anti-FXa activity decreased significantly, with maximum decreases of ≈93% (P < .05) and ≈82% (P < .05), respectively, compared with placebo. The stoichiometric ratios of andexanet alfa:total anticoagulant at maximum reversal of anti-FXa activity ranged from 1:1 to 1.3:1 for rivaroxaban and 1.41:1 to 2.58:1 for edoxaban. Sustained normalization of thrombin generation for ≈2 hours and sustained decrease in unbound anticoagulant (maximum ≈80%) for up to ≈4 hours following completion of andexanet alfa administration, compared with placebo, were observed when andexanet was administered as a bolus or as a bolus followed by continuous infusion. Andexanet alfa was well tolerated, and there were no serious adverse events or thrombotic events. Andexanet alfa has been approved in the United States and Europe for reversal of anticoagulation in patients treated with rivaroxaban or apixaban who experience life-threatening or uncontrolled bleeding. These studies were registered with clinicaltrials.gov (#NCT03578146 and #NCT03551743).
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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.