NIPH Clinical Trials Search

JRCT ID: jRCTs051220095

Registered date:15/09/2022

Modified Apixaban in Japanese Patients with Cancer-Associated Venous Thromboembolism

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedcancer-associated thromboembolism
Date of first enrollment30/09/2022
Target sample size80
Countries of recruitment
Study typeInterventional
Intervention(s)Apixaban treatment was according to the following dosage and administration; it was initiated at 10 mg twice daily for 7 days, followed by 2.5 mg twice daily for 23 weeks.


Primary Outcomethe composite of major and clinically relevant nonmajor bleeding
Secondary Outcomethe composite of recurrent VTE and VTE-related death major bleeding the composite of major, clinically relevant non-major and minor bleeding events event-free survival all-cause death hospitalization period

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1) 20 years or older 2) Any type of cancer that meets at least one of the following: a) diagnosis of cancer within six months before the study inclusion b) receiving treatment for cancer at the time of inclusion or any treatment for cancer during 6 months prior to inclusion c) recurrent locally advanced or metastatic cancer d) hematological cancer that is not in complete remission (other than leukemia) 3) Consecutive patients with a newly diagnosed, objectively confirmed: a) symptomatic or asymptomatic, pulmonary embolism b) symptomatic or asymptomatic, proximal upper or lower-limb deep vein thrombosis c) symptomatic or asymptomatic, vein thromboembosis of neck and trunk d) symptomatic distal upper or lower-limb deep vein thrombosis e) asymptomatic distal upper or lower-limb deep vein thrombosis which had proximal extension after serial imaging 4) Signed and dated informed consent, available before the start of any specific trial procedure
Exclude criteria1) Circulatory instability such as prolonged shock or hypotension 2) Any type of antithrombotic therapy to manage the index episode that meets the following: a) thrombectomy b) thrombolysis c) administration of therapeutic doses of unfractionated heparin for more than 72 hours before randomization *vena cava filter insertion is allowed. 3) indication for anticoagulant treatment for a disease other than the index VTE episode 4) use of a factor Xa inhibitor within the previous 3 months 5) concomitant thienopyridine therapy(clopidogrel, prasugrel, orticagrelor) 6) active bleeding or bleeding tendency 7) recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery 8) uncontrolled hypertension (systolic BP upper than 180 mm Hg or diastolic BP upper than 100 mm Hg despite antihypertensive treatment) 9) concomitant use of HIV protease inhibitors 10) concomitant use of azole antifungal agents or macrolide antibiotic 11) ECOG Performance Status III or IV 12) life expectancy of less than 6 months 13) laboratory abnormal data that meet the following: a) hemoglobin level lower than 8 g/dL b) platelet count less than 75x10^9/L c) creatinine clearance lower than 30 ml /min based on the Cockcroft Gault equation d) an aspartate aminotransferase or alanine aminotransferase level 3 times or higher the upper limit of the normal range e) bilirubin level 2 times or higher the upper limit of the normal range f) prothrombin time-international normalized ratio lower than 1.6 14) acute hepatitis, chronic active hepatitis, liver cirrhosis 15) hypersensitivity to the study drugs or to any of their excipients 16) pregnancy, or breastfeeding 17) any condition that, as judged by the investigate or, would place the subject at increased risk of harm if he/she participated in the study.

Related Information


Public contact
Name Taku Nose
Address 5-2, Kusunoki-cho7, Chuo-ku,Kobe-shi,Hyougo Hyogo Japan 650-0017
Telephone +81-78-382-5820
Affiliation Kobe University Hospital
Scientific contact
Name Hironobu Minami
Address 5-2, Kusunoki-cho7, Chuo-ku,Kobe-shi,Hyougo Hyogo Japan 650-0017
Telephone +81-78-382-5820
Affiliation Kobe University Hospital