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Not yet recruiting NCT06149533

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

Phase III Interventional Thrombosis, Venous Cancer Catheter Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Edoxaban.
Who it may be relevant to
Registry conditions: Thrombosis, Venous, Cancer, Catheter Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • The incidence of catheter-related thrombosis during catheter [Time frame: 6 months]
Secondary outcome measures (4)
  • The incidence of bleeding caused by edoxaban [Time frame: 6 months]
  • The mortality rate caused by catheter-related thrombosis [Time frame: 6 months]
  • The time of non thrombotic events [Time frame: 6 months]
  • The incidence of venous thrombosis [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Conditions considered unsuitable for inclusion in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chine — Beijing

Identifiers

NCT: NCT06149533 · NCC4268

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗