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VMX-C001

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.

Table of Contents

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.[1]

This trial compares VMX-C001 with usual pharmacological care, which means the standard medicine-based care used in this situation.[1]

The study is authorised and planned for 439 participants.[1]

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.[1]

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.[1]

What is being measured

The main endpoint is the proportion of participants with good or excellent haemostatic efficacy during the required procedure.[1]

Endpoint means the main result the researchers want to measure.[1]

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.[1]

Trial phase and design

This is an interventional study, so researchers are giving a treatment and then checking the results.[1]

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.[1]

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.[1]

Why this trial matters

Urgent surgery in people taking a Factor Xa anticoagulant can be difficult because bleeding control is very important.[1]

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.[1]

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.[1]

Trial ID Phase Condition studied Status Enrollment
NCT07288489 Phase 3 Patients on Factor Xa inhibitor treatment needing an urgent intervention associated with a high risk of bleeding Authorised 439

FAQ

  • What is being studied in VMX-C001 clinical trials? The trial is studying whether VMX-C001 helps with bleeding control during urgent surgery or an invasive procedure. The main focus is how well it supports haemostasis, which means stopping bleeding.
  • Who can take part in the trial? The trial is for patients who are taking a Factor Xa direct oral anticoagulant and need an urgent intervention with a high risk of bleeding. These are people who may need surgery or another procedure quickly.
  • What phase is the VMX-C001 trial? This is a Phase 3 trial. Phase 3 studies usually compare a treatment with standard care in a larger group of people to see how well it works.
  • What is the trial comparing VMX-C001 with? VMX-C001 is being compared with usual pharmacological care. This means the study looks at whether VMX-C001 performs better, worse, or similarly to the current standard treatment approach.
  • What is the main result the trial is measuring? The main result is the proportion of participants with good or excellent haemostatic efficacy during the procedure. In simple terms, the study measures how well bleeding is controlled.

Ongoing Clinical Trials on VMX-C001

  • VMX-C001 in Patients Taking Factor Xa Inhibitors Who Need Urgent Surgery or an Invasive Procedure With High Bleeding Risk

    Not yet recruiting

    3 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Estonia France +9

Glossary

  • Factor Xa direct oral anticoagulant (FXa DOAC): A blood thinner taken by mouth that blocks Factor Xa, a protein involved in blood clotting. In this trial, participants are already taking one of these medicines.
  • Urgent surgery: An operation that cannot wait for a long time and must be done soon because of the medical situation.
  • Invasive procedure: A medical test or treatment that enters the body, such as through a cut, tube, or instrument.
  • High risk of bleeding: A situation where a person is more likely to bleed a lot during or after a procedure.
  • Haemostasis: The body’s process of stopping bleeding.
  • Haemostatic efficacy: How well a treatment helps control bleeding during a procedure.
  • Independent blinded EAC: A separate expert group that reviews results without knowing which treatment the participant received, to keep the assessment fair.
  • Usual pharmacological care: The standard medicine-based care normally used in this situation.
  • Interventional study: A clinical trial where researchers give a treatment and measure what happens.

References