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)

未提供0 个研究点目标入组 800 人开始时间: 待定

试验速览

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

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

发起方

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