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 States800 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 range18 Years
SexALL
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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
✕. 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.
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).