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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)

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. (EQUILIBRIX-S)

Sasaki Yosuke

Fortrea Japan K.K.

Harumi Triton Square Office Tower Y 8F, 1-8-11, Harumi, Chuo-ku, Tokyo

Yosuke.Sasaki@fortrea.com

Sasaki Yosuke

Fortrea Japan K.K.

Harumi Triton Square Office Tower Y 8F, 1-8-11, Harumi, Chuo-ku, Tokyo

+81-90-2539-0077

Yosuke.Sasaki@fortrea.com

Recruiting

June. 09, 2026

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

prevention purpose

1. Male or female patient aged >=18 years.
2. The patient or legally authorised representative (LAR) has given written informed consent.
3. The patient requires urgent surgery/procedure for which the risk of bleeding is considered high and for which haemostasis is considered necessary.
4. The patient has a significant FXa DOAC level at the time of procedure.
5. The patient would require treatment (usual pharmacological care) to restore coagulation for the required procedure.
6. The patient must be willing to use appropriate contraception.

1. 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.
2. 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.
3. The patient has received any of the prespecified medications not allowed in the 7 days prior to Randomisation.
4. The patient was treated with an investigational drug <30 days or 5 half-lives, whichever is longer, prior to Screening.
5. Expected survival, in the Investigator's judgement, is <3 months due to comorbidity.
6. Patients in whom the Investigator considers it is not possible to estimate the expected blood loss.
7. Known "Do Not Resuscitate" order or similar advanced directive.
8. Cardiogenic shock at the time of screening unless related to the need for the required procedure.
9. The patient has sepsis (including severe sepsis or septic shock) at the time of screening.
10. The patient is pregnant or a lactating female.

Both

Due to character limits, it is written Note 1.

VMX-C001 is given by intravenous injection in advance of surgery/procedure.

Proportion of participants with good or excellent haemostatic efficacy during the required procedure.

+81-96-384-2111

May. 12, 2026

Yes

VarmX will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external, verified, qualified scientific and medical researchers. Information on the process and requirements for submitting a voluntary data sharing request for IPD can be obtained from info@varmx.com

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