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Trial Title:
Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients
NCT ID:
NCT06149533
Condition:
Thrombosis, Venous
Cancer
Catheter Complications
Conditions: Official terms:
Thrombosis
Venous Thrombosis
Edoxaban
Conditions: Keywords:
Prevention
Catheter-related Thrombosis
Cancer
Edoxaban
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A total of 366 patients with cancers who will be assessed as high risk by the thrombosis
risk prediction model (refer to Appendix 1) are planned to be enrolled. All patients are
planned to undergo anti-tumor chemotherapy and receive CVC or PICC catheterization on the
first day of chemotherapy. The patients are randomly divided into the experimental group
and the control group at a ratio of 1:1. The experimental group is treated with edoxaban
to prevent catheter-related thrombosis, and the control group won't be treated with
edoxaban.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Edoxaban
Description:
Edoxaban, an oral selective factor Xa inhibitor, had been approved by the National
Medical Products Administration in 2018. It is used for the treatment and recurrence
prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adults.
Arm group label:
The cohort 1
Summary:
To evaluate the efficacy and safety of edoxaban in the prevention of tumor
catheter-related thrombosis (CVC/PICC) in high-risk patients
Detailed description:
This study was a prospective, interventional, open, randomized controlled clinical study.
A total of 366 patients with cancers who will be assessed as high risk by the thrombosis
risk prediction model (refer to Appendix 1) are planned to be enrolled. All patients are
planned to undergo anti-tumor chemotherapy and receive CVC or PICC catheterization on the
first day of chemotherapy. The patients are randomly divided into the experimental group
and the control group at a ratio of 1:1. The experimental group is treated with edoxaban
to prevent catheter-related thrombosis, and the control group won't be treated with
edoxaban. Venous vascular ultrasound will be conducted before the start of each cycle of
chemotherapy or whenever patients have any thrombosis-related symptoms to assess whether
they have catheter-related thrombosis. The incidence of catheter-related thrombosis
during catheter. 1. The safety of edoxaban.2. The death caused by catheter-related
thrombosis.3. The time of non thrombotic events.4. The incidence of venous thrombosis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age≥18.
2. Cancer patients with a catheter-related thrombus risk prediction model score ≥ 19.6.
3. ECOG score≤2.
4. Expected survival period over 6 months.
5. Malignant tumor was diagnosed by pathology and central venous catheterization was
successfully completed.
6. Signing of informed consent voluntarily.
Exclusion Criteria:
1. Unknown location of the primary tumor.
2. Allergy to the active ingredient of edoxaban tablets or other excipients.
3. There is clinically significant active bleeding.
4. Platelet <50×109/L.
5. Liver disease with coagulopathy or clinically relevant bleeding risk.
6. A lesion or condition with a significant risk of major bleeding, such as current or
recent gastrointestinal ulcer, recent brain or spinal injury, recent brain, spinal,
or ophthalmic surgery, recent intracranial hemorrhage, esophageal varices,
arteriovenous malformations, vascular aneurysms, or major intravertebral or
intracerebral vascular malformations.
7. Concomitant therapy with any other anticoagulant, such as Unfractionated heparin
(UFH), Low molecular heparin (Low molecular weight heparin, LMWH) (enoxaparin,
dalteparin, etc.), heparin derivative (fondaparinux, etc.), oral anticoagulant
(warfarin, dabigatran, rivaroxaban, apixaban, etc.), except in the special case of
administration of UFH to maintain central venous catheter patency.
8. Surgical treatment is planned for the duration of the study.
9. Uncontrolled co-morbidities include, but are not limited to:
Serious, uncontrolled infection. Symptomatic heart failure (New York Heart
Association class II-IV) or symptomatic or poorly controlled arrhythmias
Uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood
pressure ≥100mmHg) despite standard treatment.
Any arterial thromboembolic event within 6 months before enrollment. Tumor invasion
of large vessels. History of deep vein thrombosis, pulmonary embolism, or other
major thromboembolism within 3 months before enrollment.
10. History of gastrointestinal perforation within 6 months before enrollment.
11. Pregnant or breastfeeding women.
12. Oral contraceptives.
13. Conditions considered unsuitable for inclusion in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100021
Country:
China
Start date:
November 30, 2023
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06149533
