Trial reportJournal of cardiovascular pharmacology2026
Reversal of the Anticoagulant Effect of Milvexian by 4-Factor PCC and rFVIIa in Healthy Participants: A Two-Part, Randomized, Crossover Study.
Trial report in Journal of cardiovascular pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Translational Development of Oral FXIa Inhibitors: A Systematic Review of Molecular Design, Pharmacology, and Indication-Specific Clinical Evidence.Pharmaceuticals (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
abstractMilvexian is a selective, oral factor XIa inhibitor. Individuals receiving anticoagulation may require prompt reversal of anticoagulative effects. This study assessed reversal of milvexian's anticoagulant effects by recombinant human factor VIIa (rFVIIa) and 4-factor prothrombin complex concentrate (4F-PCC) in healthy participants. This was a 2-part, randomized, crossover study. In part A, milvexian (100 or 500 mg single doses) was followed by rFVIIa (30 μg/kg) or placebo 4 hours later. In part B, milvexian 200 mg was administered q12h for 3 consecutive days, with 4F-PCC (50IU/kg) or placebo given 4 hours after last dose in the morning of day 4. Anticoagulation was assessed through activated partial thromboplastin time (aPTT) and thrombin generation [endogenous thrombin potential (ETP), peak thrombin] using 2 activators: kaolin [intrinsic pathway (IP) effects] and tissue factor [extrinsic pathway (EP) effects]. rFVIIa partially reversed milvexian's effects on aPTT (milvexian 100 mg: ∼18%; 500 mg: ∼15%), IP-induced ETP (milvexian-induced ETP reversal; 100 mg: ∼50%; 500 mg: ∼80%) and peak thrombin, and EP-induced peak thrombin but not ETP. Milvexian 200 mg prolonged aPTT, strongly inhibited IP-induced ETP/peak thrombin, and mildly inhibited EP-induced ETP. 4F-PCC partially reversed milvexian's effect on aPTT (∼17%) and IP-induced ETP/peak thrombin; it reversed milvexian's effect on EP-initiated ETP (∼68% increase). Reversal was rapid (15 minutes) and long-lasting (≥8 hours). Milvexian pharmacokinetics were unchanged by reversal agents. Regimens were generally safe and well tolerated. In conclusion, milvexian's anticoagulant effect was partially reversed by rFVIIa and 4F-PCC. These results may offer clinicians options in situations where reversal of milvexian might be considered.
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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 Socratic graph.