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RECRUITINGPHASE3

A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery

A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial With Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure

NCT05156983•Takeda

View on ClinicalTrials.gov

Summary

The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in participants treated with Factor Xa inhibitors who require urgent surgery/invasive procedure. The participant will be assigned by chance to either TAK-330 or SOC 4F-PCC as part of standard treatment before surgery. Patients participating in this study will need to be hospitalized. They will also be contacted (via telehealth/phone call) 30 days after the surgery.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant or legally authorized representative willing to sign e-consent/written informed consent form.
•Participants at least 18 years of age at enrollment.
•Participant currently on treatment with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).
•In the opinion of the surgeon, the participant requires an urgent surgery/procedure that is associated with high-risk of intraoperative bleeding within 15 hours from the last dose of Factor Xa inhibitor and requires a reversal agent for suspected direct oral Factor Xa inhibitor-related coagulopathy. For participants who are beyond the 15-hour window, eligibility requires proof of elevated plasma anti-Factor Xa (FXa) levels using either specific direct oral anti-coagulant (DOAC)-calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels of greater than (\>) 75 nanograms per milliliter (ng/mL), or heparin calibrated anti-FXa assay levels of \>0.5 international unit per milliliter (IU/mL) at screening.
•Women of childbearing potential should have a negative pregnancy test documented prior to enrollment.

Exclusion Criteria

•The participant has an expected survival of less than 30 days, even with best available medical and surgical care.
•Recent history (within 90 days prior to screening) of venous thromboembolism, myocardial infarction (MI), disseminated intravascular coagulation (DIC), ischemic stroke, transient ischemic attack, hospitalization for unstable angina pectoris or severe or critical coronavirus 2 (SARS-CoV-2) infection.
•Active major bleeding defined as bleeding that requires surgery or transfusion of \>2 units of packed red blood cell (PRBC) or intracranial hemorrhage with the exception of subacute and chronic subdural hemorrhages with a Glasgow Coma Score (GCS) greater than or equal to (\>=) 9.
•Polytrauma for which reversal of Factor Xa-inhibition alone would not be sufficient to achieve hemostasis.
•Known prothrombotic disorder including primary antiphospholipid syndrome, antithrombin-3 deficiency, homozygous protein C deficiency, homozygous protein S deficiency, and homozygous factor V Leiden.
•Known bleeding disorder (example, platelet function disorders, hemophilia, Von Willebrand disease, or coagulation factor deficiency).
•Platelet count less than (\<) 50,000 per microliter (/mcL).
•History of heparin-induced thrombocytopenia.
•Planned use of procoagulant drugs (example, Vitamin K, non-study PCCs, recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) after enrollment but before the 24±4 hours hemostatic assessment (Key secondary endpoint). Planned administration of tranexamic acid (TXA) or aminocaproic acid after randomization but before the start of IP infusion, should be noted during randomization to properly stratify these participants in the interactive response technology (IRT). Planned administration of TXA or aminocaproic acid after start of IP infusion but before the 24±4 hours hemostatic assessment is prohibited. Administration of any of the above products before the 24±4 hours hemostatic assessment will impact the assessment of hemostasis. Administration of PRBCs for hemoglobin correction, is not an exclusion criterion.
•Administration of unfractionated heparin within 2 hours before randomization or low molecular weight heparin within 6 hours before randomization.
+9 more criteria

Locations (64)

University of Arkansas Medical Sciences

Arkansas City, Arkansas, United States

University of California Davis Health System

Sacramento, California, United States

Denver Metro Orthopedics, P.C.

Englewood, Colorado, United States

University of Florida

Gainesville, Florida, United States

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, United States

ECU Health Medical Center

Greenville, North Carolina, United States

Metro Health Medical Center

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Ascension St. John Medical Center

Tulsa, Oklahoma, United States

University of Pennsylvania - Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

August 24, 2022

Primary Completion Date

April 12, 2028

Completion Date

April 12, 2028

Last Updated

January 28, 2026

Enrollment

328

ESTIMATED participants

Conditions

Coagulation Disorder

Interventions

TAK-330

DRUG

SOC 4F-PCC

DRUG

Contacts

Takeda Contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery

Inclusion Criteria

Exclusion Criteria

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