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.

Part of paid clinical trials in Chandler, Arizona.

Sponsor
VarmX B.V.
Study ID
NCT07288489
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Blood Loss, Surgical
  • Coagulation Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VMX-C001 — DRUG
    A fixed dose of VMX-C001 will be administered prior to commencement of procedure.
  • Usual Pharmacological Care — DRUG
    Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2031

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VMX-C001
    Participants will be administered a fixed dose of VMX-C001 before undergoing the required procedure.
  • Active Comparator: Usual Pharmacological Care
    Participants will be given the usual treatment used by the site for patients receiving FXa DOACs when undergoing the required procedure.

Primary Outcome Measure

Effect of VMX-C001 versus usual pharmacological care on haemostasis [ Time Frame: From start to end of required procedure (Day 1). ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Chandler Regional Medical Center (CRMC)ChandlerArizona85224-
HonorHealth John C Lincoln Medical CenterPhoenixArizona85020-
St. Joseph's Hospital and Medical CenterPhoenixArizona85013-
Stanford Hospital and ClinicsStanfordCalifornia94305-
Denver Metro Orthopedics, P.C. - Englewood LocationEnglewoodColorado80113-
Medical Center of the RockiesFort CollinsColorado80523-
Christiana CareNewarkDelaware19718-
University of South FloridaTampaFlorida33606-
University of Iowa Health CareIowa CityIowa52242-
Massachusetts General HospitalBostonMassachusetts02114-
Beaumont Hospital, Royal OakRoyal OakMichigan48073-
William Beaumont Hospital - Troy CampusTroyMichigan48085-
Duke University Medical CenterDurhamNorth Carolina27710-
The University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73126-
Texas Tech University Health Sciences Center - El PasoEl PasoTexas79905-
The University of Texas McGovern Medical School at HoustonHoustonTexas77030-

Find similar trials in Chandler, AZ

By research site
Chandler Regional Medical Center (CRMC)· Chandler, AZHonorHealth John C Lincoln Medical Center· Phoenix, AZSt. Joseph's Hospital and Medical Center· Phoenix, AZStanford Hospital and Clinics· Stanford, CADenver Metro Orthopedics, P.C. - Englewood Location· Englewood, COMedical Center of the Rockies· Fort Collins, CO

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