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

NCT06149533 | Not Yet Recruiting Phase 3

• 1 other identifier: NCC4268
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thrombosis, Venous; Cancer; Catheter Complications

Keywords

Prevention; Catheter-related Thrombosis; Cancer; Edoxaban

Outcome Measures

Primary Outcomes (1)

• The incidence of catheter-related thrombosis during catheter

  6 months

Secondary Outcomes (4)

• The incidence of bleeding caused by edoxaban

  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

Study Arms (2)

The cohort 1

EXPERIMENTAL

The cohort 1 is treated with edoxaban to prevent catheter-related thrombosis.

Drug: Edoxaban

The cohort 2

NO INTERVENTION

The cohort 2 won't be treated with edoxaban.

Interventions

Edoxaban DRUG

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.

The cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18.
• Cancer patients with a catheter-related thrombus risk prediction model score ≥ 19.6.
• ECOG score≤2.
• Expected survival period over 6 months.
• Malignant tumor was diagnosed by pathology and central venous catheterization was successfully completed.
• Signing of informed consent voluntarily.

You may not qualify if:

• Unknown location of the primary tumor.
• Allergy to the active ingredient of edoxaban tablets or other excipients.
• There is clinically significant active bleeding.
• Platelet \<50×109/L.
• Liver disease with coagulopathy or clinically relevant bleeding risk.
• 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.
• 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.
• Surgical treatment is planned for the duration of the study.
• 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.
• History of gastrointestinal perforation within 6 months before enrollment.
• Pregnant or breastfeeding women.
• Oral contraceptives.

Sponsors & Collaborators

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

Study Sites (1)

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

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Venous Thrombosis; Neoplasms

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

fei ma

CONTACT

+8613910217780; drmafei@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Medical Oncology

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 29, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)