Phase 3 trial of VMX-C001 vs usual pharmacological care in patients taking a FXa direct oral anticoagulant who require urgent surgery with or without heparin (NCT07288489)

The purpose of this study is to test the ability of an experimental drug (study drug) named VMX-C001 to bypass the effect of a medication that you are currently taking known as a FXa direct oral anticoagulant (FXa DOAC). FXa DOACs are anticoagulant (blood-thinning) drugs that reduce the risk of blood clots but increase the risk of bleeding. Therefore, in certain situations, patients taking FXa DOACs need to receive other drugs that can restore the ability of their blood to clot (coagulation), as in the cases of serious bleeding or when requiring urgent surgery or another procedure that is associated with a high risk of bleeding. Because you may have taken an FXa DOAC within the last 15 hours, it is usual for your medical team to want to restore coagulation during the surgery to prevent excessive bleeding. The main purpose of this research study is to: Evaluate the safety of the study drug, VMX-C001; Determine the efficacy of VMX-C001 (how well the drug works); Assess the pharmacokinetics (PK) of VMX-C001 (PK; how the drug is processed through your body); Assess the immunogenicity of VMX-C001 (how the drug works on your immune system).

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Dev Mitra

Key inclusion data

Aged 18 years or older. Currently taking a FXa DOAC [rivaroxaban (often called: Xarelto), apixaban (often called: Eliquis). Requires urgent surgery/procedure for which the risk of bleeding (≥ 50ml during surgery) is considered high and for which haemostasis is considered necessary: intra‐abdominal surgery, intrathoracic surgery, intracranial surgery, orthopaedic surgery, peripheral arterial surgery, trauma surgery, other invasive procedures, any other procedure lasting ≥1 hour. Usual pharmacological care for urgent surgery/required procedure would include one of the following: Prothrombin complex concentrate (PCC) products, Anti-inhibitor coagulant complex / aPCC / FEIBA, Andexanet alfa, Does not have a "Do Not Resuscitate" order or similar advanced directive, Does not have sepsis, Has not received heparin within 3 days of screening.