Phase 3 Trial of VMX-C001 Versus Usual Care in Patients on Factor Xa DOACs Requiring Urgent High-Bleeding-Risk Surgery or Invasive Procedures

The primary objective is to evaluate the effect of VMX-C001 versus usual pharmacological care on haemostasis during urgent surgery or other invasive procedures in patients receiving a FXa DOAC. This is clinically relevant because effective control of haemostasis is central to reducing bleeding risk in the setting of urgent intervention. No secondary objectives are specified.

The trial population consisted of 357 male and female participants, including vulnerable individuals, aged 18 years and older, with a body weight of at least 40 kg. Participants were patients on Factor Xa inhibitor treatment who required an urgent surgery or invasive procedure associated with a high risk of bleeding, and who had a significant FXa DOAC level at the time of the procedure. The population was selected from patients for whom usual pharmacological care for the urgent intervention would include one of the prespecified medications. Relevant lifestyle-related requirements included contraception measures for male participants and women of childbearing potential, including avoidance of sperm donation for male participants and use of highly effective contraception by women of childbearing potential. Written informed consent was required.

This is a randomized, prospective, phase 3, controlled clinical trial evaluating VMX-C001 versus usual pharmacological care in adults receiving a factor Xa direct oral anticoagulant who require urgent surgery or another invasive procedure with a high risk of bleeding. The main objective is to assess haemostatic efficacy during the required procedure, as determined by an independent blinded endpoint assessment committee. The overall trial duration is planned from 15 June 2026 to 6 February 2031. Study participation begins with a screening visit to confirm eligibility, including informed consent, clinical criteria, anticoagulant level assessment, and pregnancy testing where applicable. Eligible participants then receive study treatment in the setting of the urgent procedure, followed by any protocol-specified follow-up assessments and an end-of-study visit to complete final evaluations. The expected participant involvement extends from screening through the end-of-study assessment, with duration determined by the timing of the urgent procedure and subsequent follow-up. Early termination from the study may occur if withdrawal of consent is made, if eligibility criteria are no longer met, or if continuation is not possible for safety or other protocol-defined reasons.

VMX-C001 was administered as a solution for infusion at a dose of 00000 mg by the intravenous route. The dosing frequency was not specified in the source data. Administration occurred in the setting of a phase 3 randomized clinical trial evaluating haemostasis during urgent surgery or other invasive procedures in participants receiving a FXa direct oral anticoagulant.

The comparator treatment was usual pharmacological care. The source data did not specify the individual components of this non-experimental treatment. Planned administration of heparin could occur in the study, but the source data did not provide further details. Information on dosing schedules and compliance monitoring was not specified.

Efficacy will be assessed by the proportion of participants with good or excellent haemostatic efficacy during the required procedure. This outcome will be determined by an independent blinded EAC.