Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
Public ClinicalTrials.gov record NCT07288489. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Prospective Randomised Clinical Trial of VMX-C001 vs Usual Pharmacological Care in Patients Receiving a FXa Direct Oral Anticoagulant (FXa DOAC) Who Require Urgent Surgery or Other Invasive Procedure That is Associated With a High Risk of Bleeding, With or Without Planned Administration of Heparin (EQUILIBRIX-S)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to learn if reltodecacog alfa (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 reltodecacog alfa (VMX-C001) to the usual treatment that would be given for the required procedure. Participants will: * Be given either a fixed dose of reltodecacog alfa (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.
Study identification
- NCT ID
- NCT07288489
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 800 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 18, 2026 (Actual)
- Primary completion
- Jan 2029 (Estimated)
- Completion
- Jan 2031 (Estimated)
- Last update posted
- Oct 14, 2026
2026 – 2031
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Chandler Regional Medical Center (CRMC) | Chandler | Arizona | 85224 | Recruiting |
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | Not yet recruiting |
| HonorHealth John C Lincoln Medical Center | Phoenix | Arizona | 85020 | Recruiting |
| Stanford Hospital and Clinics | Stanford | California | 94305 | Not yet recruiting |
| Denver Metro Orthopedics, P.C. - Englewood Location | Englewood | Colorado | 80113 | Not yet recruiting |
| Medical Center of the Rockies | Fort Collins | Colorado | 80523 | Not yet recruiting |
| Christiana Care | Newark | Delaware | 19718 | Not yet recruiting |
| University of South Florida | Tampa | Florida | 33606 | Recruiting |
| University of Iowa Health Care | Iowa City | Iowa | 52242 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Not yet recruiting |
| Beaumont Hospital, Royal Oak | Royal Oak | Michigan | 48073 | Not yet recruiting |
| William Beaumont Hospital - Troy Campus | Troy | Michigan | 48085 | Not yet recruiting |
| Duke University Medical Center | Durham | North Carolina | 27710 | Not yet recruiting |
| Ohio State McCampbell Outpatient Care | Columbus | Ohio | 43210 | Recruiting |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73126 | Recruiting |
| Texas Tech University Health Sciences Center - El Paso | El Paso | Texas | 79905 | Not yet recruiting |
| Memorial Hermann Hospital-TMC Investigational Drugs Services Pharmacy | Houston | Texas | 77030 | Recruiting |
| The University of Texas McGovern Medical School at Houston | Houston | Texas | 77030 | Not yet recruiting |
| Intermountain Medical Center | Murray | Utah | 84107 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 57 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07288489, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07288489 live on ClinicalTrials.gov.