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Phase 3 Trial of TAK-330 for Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation
EU CTIS ID: 2022-503012-16-00
What this study is testing
To evaluate intraoperative efficacy of TAK-330 in comparison with standard of care (SOC) 4F-PCC, for reversal of anticoagulation in patients receiving direct oral Factor Xa inhibitors and requiring urgent surgery/invasive procedure within 15 hours from the last dose of Factor Xa inhibitor or at any time after that if their specific DOAC calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels were > 75ng/mL or heparin-calibrated anti FXa assay level of > 0.5 IU/mL at screening.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient or legally authorized representative willing to sign e-consent/written informed consent form (ICF).
- Patients ≥ 18 years of age at enrollment.
- Patient currently on treatment with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).
- In the opinion of the surgeon, the patient requires urgent surgery/procedure that is associated with high-risk of intraoperative bleeding within 15 hours of the last Factor Xa inhibitor dose and requires a reversal agent for suspected direct oral Factor Xa inhibitor-related coagulopathy. In patients who are beyond the 15-hour window, eligibility requires proof of elevated plasma anti FXa levels using either specific DOAC-calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels of > 75ng/mL, or heparin-calibrated anti-FXa assay levels of > 0.5 IU/mL at screening.
- Women of childbearing potential should have a negative pregnancy test documented prior to enrollment.
You likely can't join if
- The patient has an expected survival of less than 30 days even with best available medical and surgical care.
- Planned use of procoagulant drugs (e.g., Vitamin K, non-study PCCs, recombinant Factor VIIa) or blood products (transfusion of whole blood, FFP, cryoglobulins, plasma fractions, or platelets) after enrollment but before the 24±4 hours hemostatic assessment (Key secondary endpoint). Planned administration of TXA or aminocaproic acid after randomization but before the start of IP infusion, should be noted during randomization to properly stratify these patients in the 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.
- Hypersensitivity to PCC constituents, or any excipient of TAK-330.
- Patients with history of confirmed immunoglobulin A (IgA) deficiency with hypersensitivity reaction and antibodies to IgA.
- Septic shock as defined by persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 65mmHg and having blood lactate > 2 mmol despite adequate volume resuscitation.
See the full eligibility criteria
Who can join
- Patient or legally authorized representative willing to sign e-consent/written informed consent form (ICF).
- Patients ≥ 18 years of age at enrollment.
- Patient currently on treatment with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).
- In the opinion of the surgeon, the patient requires urgent surgery/procedure that is associated with high-risk of intraoperative bleeding within 15 hours of the last Factor Xa inhibitor dose and requires a reversal agent for suspected direct oral Factor Xa inhibitor-related coagulopathy. In patients who are beyond the 15-hour window, eligibility requires proof of elevated plasma anti FXa levels using either specific DOAC-calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels of > 75ng/mL, or heparin-calibrated anti-FXa assay levels of > 0.5 IU/mL at screening.
- Women of childbearing potential should have a negative pregnancy test documented prior to enrollment.
What rules you out
- The patient has an expected survival of less than 30 days even with best available medical and surgical care.
- Planned use of procoagulant drugs (e.g., Vitamin K, non-study PCCs, recombinant Factor VIIa) or blood products (transfusion of whole blood, FFP, cryoglobulins, plasma fractions, or platelets) after enrollment but before the 24±4 hours hemostatic assessment (Key secondary endpoint). Planned administration of TXA or aminocaproic acid after randomization but before the start of IP infusion, should be noted during randomization to properly stratify these patients in the 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.
- Hypersensitivity to PCC constituents, or any excipient of TAK-330.
- Patients with history of confirmed immunoglobulin A (IgA) deficiency with hypersensitivity reaction and antibodies to IgA.
- Septic shock as defined by persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 65mmHg and having blood lactate > 2 mmol despite adequate volume resuscitation.
- Acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C).
- Renal failure requiring dialysis.
- Any other condition that could, in the opinion of the investigator, put the patient at undue risk of harm if the patient were to participate in the study.
- Participation in another clinical study involving an investigational product or device within 30 days prior to study enrollment, or planned participation in another clinical study involving an investigational product or device during the course of this study. Participation in an observational study is not an exclusion criterion.
- The use of PROTHROMPLEX TOTAL as SOC 4F-PCC.
- Recent history (within 90 days prior to screening) of venous thromboembolism, myocardial infarction (MI), DIC, ischemic stroke, transient ischemic attack, hospitalization for unstable angina pectoris or severe or critical coronavirus 2 (SARS-CoV-2) infection.
- Women who are breastfeeding at the time of enrollment.
- Active major bleeding defined as bleeding that requires surgery or transfusion of > 2 units of PRBC or intracranial hemorrhage with the exception of subacute and chronic subdural hemorrhages with a Glasgow Coma Score (GCS) ≥ 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 disorders (e.g., platelet function disorders, hemophilia, Von Willebrand disease, coagulation factor deficiency).
- Platelet count < 50,000/μL.
- History of heparin-induced thrombocytopenia.
- Administration of procoagulant drugs (e.g., non-study PCCs, recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma (FFP), cryoglobulins, plasma fractions, or platelets) within 7 days before enrollment (Note: administration of packed red blood cells (PRBCs) for hemoglobin correction, tranexamic acid or aminocaproic acid are not exclusion criteria).
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.