Clinical trial NCT06149533: Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients
Official title: A Randomized, Multicenter, Open-Label, Control, Clinical Trial to Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Thrombosis, Venous
Cancer
Catheter Complications
Keywords: Prevention
Catheter-related Thrombosis
Cancer
Edoxaban
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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.

Primary outcomes:
measure: The incidence of catheter-related thrombosis during catheter
timeFrame: 6 months
Secondary outcomes:
measure: The incidence of bleeding caused by edoxaban
timeFrame: 6 months
measure: The mortality rate caused by catheter-related thrombosis
timeFrame: 6 months
measure: The time of non thrombotic events
timeFrame: 6 months
measure: The incidence of venous thrombosis
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
References: