In short
Clinical trials are studying VMX-C001 in people who take a Factor Xa direct oral anticoagulant and need urgent surgery or another high-bleeding-risk procedure. These trials aim to see how well it supports bleeding control during the procedure and how it compares with usual pharmacological care.
Key points
- VMX-C001 is being studied in a Phase 3 clinical trial for people who take a Factor Xa direct oral anticoagulant and need urgent surgery or another high-bleeding-risk procedure. The study is designed to compare VMX-C001 with usual pharmacological care. Researchers are mainly looking at haemostatic efficacy, which means how well bleeding is controlled during the procedure. The trial is interventional and includes 439 participants. The main condition being studied is the need for urgent intervention in patients already using Factor Xa inhibitor treatment. The trial is authorised.
Trial overview
The available study is a Phase 3 trial of VMX-C001 in patients who are taking a Factor Xa direct oral anticoagulant and need urgent surgery or another procedure with a high risk of bleeding.
This trial compares VMX-C001 with usual pharmacological care, which means the standard medicine-based care used in this situation.
The study is authorised and planned for 439 participants.
Who can participate
The trial is for patients already receiving a Factor Xa inhibitor treatment who need an urgent intervention linked to a high risk of bleeding.
In simple terms, this means the study is focused on people who are on a blood thinner and suddenly need surgery or a procedure that could cause significant bleeding.
What is being measured
The main endpoint is the proportion of participants with good or excellent haemostatic efficacy during the required procedure.
Endpoint means the main result the researchers want to measure.
Haemostatic efficacy means how well bleeding is controlled during the procedure, and the result is judged by an independent blinded EAC, which is a separate expert group that does not know which treatment the participant received.
Trial phase and design
This is an interventional study, so researchers are giving a treatment and then checking the results.
Because it is Phase 3, the trial is meant to test the treatment in a larger group and compare it with standard care in a real clinical setting.
The study title also shows that the trial is looking at VMX-C001 versus usual pharmacological care in patients who need urgent surgery, with or without heparin.
Why this trial matters
Urgent surgery in people taking a Factor Xa anticoagulant can be difficult because bleeding control is very important.
This trial is designed to help answer whether VMX-C001 can improve bleeding control during these urgent procedures compared with the care that is usually used.
For patients, the key question is whether the treatment helps the medical team achieve good or excellent control of bleeding at the time of surgery or the procedure.