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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.

NCT07288489 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Blood Loss, Surgical
  • Coagulation Disorder

Interventions

DRUG

VMX-C001

A fixed dose of VMX-C001 will be administered prior to commencement of procedure.

DRUG

Usual Pharmacological Care

Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.

Sponsors & Collaborators

  • VarmX B.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2029-01-31
Completion
2031-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07288489 on ClinicalTrials.gov