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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Catheter Complications; Thrombosis, Venous
• Intervention / Treatment: Drug: Edoxaban

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.

• Study Type: Interventional
• Enrollment (Estimated): 366
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: fei ma; Phone Number: +8613910217780; Email: drmafei@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The cohort 1; The cohort 1 is treated with edoxaban to prevent catheter-related thrombosis.	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.
No Intervention: The cohort 2; The cohort 2 won't be treated with edoxaban.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of catheter-related thrombosis during catheter	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The mortality rate caused by catheter-related thrombosis		6 months
The time of non thrombotic events		6 months
The incidence of venous thrombosis		6 months

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Prevention; Edoxaban; Catheter-related Thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban
• Other Study ID Numbers: NCC4268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: These data involve patient privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No