Clinical trial · Interventional
Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients
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
NCT06149533CI-TRIAL-00071802Thrombosisnot yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of edoxaban in the prevention of tumor catheter-related thrombosis (CVC/PICC) in high-risk patients
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Catheter Complications | — | UNRESOLVED | — |
| Thrombosis, Venous | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Edoxaban | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The cohort 1
- description
- The cohort 1 is treated with edoxaban to prevent catheter-related thrombosis.
- interventionNames
- Drug: Edoxaban
- type
- NO_INTERVENTION
- label
- The cohort 2
- description
- The cohort 2 won't be treated with edoxaban.
Primary outcomes (1)
- measure
- The incidence of catheter-related thrombosis during catheter
- timeFrame
- 6 months
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.