EQUILIBRIX-S
Research type
Research Study
Full title
A Phase 3 prospective randomised clinical trial of VMX-C001 vs usual pharmacological care in patients receiving a FXa direct oral anticoagulant (FXa DOAC) who require urgent surgery or other invasive procedure that is associated with a high risk of bleeding, with or without planned administration of heparin (EQUILIBRIX-S)
IRAS ID
1013163
Contact name
Julie Warner
Contact email
Sponsor organisation
VarmX B.V.
Eudract number
2025-521632-12
Clinicaltrials.gov Identifier
Research summary
This is a Phase 3, open label (both participants and study doctors know the treatment given) randomised study of VMX-C001. The study will look at how well VMX C001 works compared to usual care drugs in stopping bleeding during urgent surgery/other procedure in patients taking FXa DOACs. FXa DOACs are drugs used in people with heart and blood circulation problems to reduce the risk of blood clots, but they increase the risk of bleeding. This study includes 2 groups (1 group of participants will receive VMX-C001 and the other will receive usual care drugs). Each group may include up to 400 participants.
Participants who agree to take part in the study by signing the informed consent form will be assessed to check they meet the study requirements (screening). Participants who meet requirements will be randomised to receive either VMX-C001 or usual care drugs (participants have the same chance [50%] of receiving VMX-C001 or usual care drugs).
If participants develop antibodies to VMX-C001 or FX, they will be asked to enter a further phase with blood testing every 12 weeks for antibodies and blood clotting parameters. This will continue until antibodies are no longer seen, or for 2 years after study Day 28, whichever happens first.
Participants will be men or women aged 18 years or older who require urgent surgery or a procedure for which bleeding risk is high and medical treatment to stop bleeding is necessary.
Participants will have levels of FXa DOAC in their blood at the time of procedure that are known to stop normal clotting. People cannot enter the study if they (a) have an increased risk of bleeding for any reason other than taking FXa DOACs (b) are taking anti-clotting medications other than FXa DOACs within 7 days of screening or (c) have received heparin within 3 days of screening.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
26/EM/0012
Date of REC Opinion
4 Mar 2026
REC opinion
Further Information Favourable Opinion