Status:
NOT_YET_RECRUITING
Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Thrombosis, Venous
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT06149533
Start Date
November 30 2023
End Date
November 30 2026
Last Update
November 29 2023
Active Locations (1)
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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, China, 100021