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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18.

Cancer patients with a catheter-related thrombus risk prediction model score ≥ 19.6.

ECOG score≤2.

Expected survival period over 6 months.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

366 Participants
are divided into 2 treatment groups
Group A: The cohort 1Experimental treatment 1 intervention
Group B: The cohort 2No intervention 0 interventions

Trial outcomes

Primary outcomes

1

The incidence of catheter-related thrombosis during catheter

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months
2

The mortality rate caused by catheter-related thrombosis

Time frame
6 months
3

The time of non thrombotic events

Time frame
6 months
4

The incidence of venous thrombosis

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: