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.

• Status: NOT_YET_RECRUITING
• Trial end date: 2031-01-01

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 VMX-C001 to the usual treatment that would be given for the required procedure.

Participants will:

• Be given either 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.

• Phase: PHASE3

Details

• Lead Sponsor: VarmX B.V.