Modified Apixaban in Japanese Patients with Cancer-Associated Venous Thromboembolism

JRCT ID: jRCTs051220095

Registered date:15/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cancer-associated thromboembolism
• Date of first enrollment: 30/09/2022
• Target sample size: 80
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: the composite of major and clinically relevant nonmajor bleeding

Secondary Outcome

the 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 maximum: Not applicable
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Minami Hironobu