Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients

Cancer Clinical Trial

— Thrombosis  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06149533
• Other study ID #: NCC4268
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 30, 2023
• Est. completion date: November 30, 2026

Study information

• Verified date: November 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: fei ma
• Phone: +8613910217780
• Email: drmafei[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of edoxaban in the prevention of tumor catheter-related thrombosis (CVC/PICC) in high-risk patients

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 366
• Est. completion date: November 30, 2026
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Catheter Complications
• Thrombosis
• Thrombosis, Venous
• Venous Thrombosis

Intervention

Drug:
• Edoxaban
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.

Locations

Country	Name	City	State
China	National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of catheter-related thrombosis during catheter		6 months
Secondary	The incidence of bleeding caused by edoxaban	The incidence of bleeding caused by edoxaban including major bleeding, clinically relevant non-major bleeding and minor bleeding. The criteria is shown in Appendix 3.	6 months
Secondary	The mortality rate caused by catheter-related thrombosis		6 months
Secondary	The time of non thrombotic events		6 months
Secondary	The incidence of venous thrombosis		6 months