TAK-330-3001
Recruiting
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
About this clinical trial
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.
US
FR
BE
6+
Interventional Phase 3 clinical trial.
At a glance
What medical conditions are being studied?
Coagulation Disorder
What is the clinical trial testing?
TAK-330, SOC 4F-PCC
How many participants are being enrolled?
328
Are placebos part of the clinical trial?
No
When is the clinical trial being conducted?
Aug 2022 - Apr 2028
How long is participation in the clinical trial?
Each participant will be in the study for about 35 days.
Key requirements
Sexes
All
Age
18+ Years
Healthy volunteers?
No
Entry criteria
Must be women and men 18 years or older.
Must be treated with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).
Must need urgent surgery or other invasive procedures which have a high-risk of blood loss during surgery.
Cannot have an expected survival of less than 30 days.
Cannot be pregnant.
Additional entry criteria will be discussed with the study doctor.
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