Phase 3 Trial of VMX-C001 vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anti… (NCT07288489) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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.
United States, Australia, New Zealand800 participantsStarted 2026-03
Plain-language summary
The goal of this clinical trial is to learn if VMX-C001 works to to allow blood clotting control in participants who take FXa Direct Oral Anticoagulants (DOACs) during surgery or other invasive procedures that carry a high risk of bleeding. The main question it aims to answer is:
● What is the proportion of participants in whom the stopping of bleeding was classed as good or excellent during the procedure, as judged by a group of experts who did not know which treatment was given?
Researchers will compare a fixed dose of VMX-C001 to the usual treatment that would be given for the required procedure.
Participants will:
* Be given either a fixed dose of VMX-C001 or usual treatment before they undergo the required procedure in theatre
* Have regular clinical assessments, including laboratory tests, during their hospital stay following the procedure
* Return to the clinic for a check-up and tests approximately 28 days after the procedure was conducted.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female patient aged ≥18 years.
. The patient or legally authorised representative (LAR) has given written informed consent.
. The patient requires urgent surgery/procedure for which the risk of bleeding is considered high and for which haemostasis is considered necessary.
. The patient has a significant FXa DOAC level at the time of procedure.
. The patient would require treatment (usual pharmacological care) to restore coagulation for the required procedure.
. The patient must be willing to use appropriate contraception.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of VMX-C001 versus usual pharmacological care on haemostasis
Timeframe: From start to end of required procedure (Day 1).
. The patient is known for any reason, other than administration of a FXa DOAC, to have an increased risk of bleeding compared to a patient in a similar clinical situation.
. The patient has received any non FXa DOAC anticoagulants within 7 days of Screening or has received heparin (UFH or LMWH) within 3 days of Screening.
. The patient has received any of the prespecified medications not allowed in the 7 days prior to Randomisation.
. The patient was treated with an investigational drug \<30 days or 5 half-lives, whichever is longer, prior to Screening.
. Expected survival, in the Investigator's judgement, is \<3 months due to comorbidity.
. Patients in whom the Investigator considers it is not possible to estimate the expected blood loss.
. Known "Do Not Resuscitate" order or similar advanced directive.
. Cardiogenic shock at the time of screening unless related to the need for the required procedure.