Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports

March 12, 2020 updated by: tingliu, LiuZhou People's Hospital

The Efficacy and Safety of Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports: a Prospective Randomized Controlled Trial

Rivaroxaban has been developed in the various clinical settings.Although cancer-associated DVT or PE was included in previously programs, limited patients of the total populations were cancer patients with totally implantable access ports in these studies. In this sense, investigators feel that new oral anticoagulants should be re-investigated in this highly specific patients group.Therefore, investigators are planning to conduct a prospective study to estimate the efficacy and safety of rivaroxaban for thromboprophylaxis in high-risk cancer patients with totally implantable access ports.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

204

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Eligibility Criteria:

  1. Age 18-75 years;
  2. Patients with malignant tumors who received implantable access ports for treatment;
  3. Eastern Cooperative Oncology Group (ECOG) class 0-1;
  4. will have a life expectancy > 3 months;
  5. Expected survival of more than 6 months;
  6. Khorana score ≥2 point.

Exclusion Criteria:

  1. Patients with a history of allergies to rivaroxaban;
  2. History of recent major or clinically relevant bleeding within the previous 4 weeks.
  3. Patients with bleeding risks: thrombocytopenia (platelet count < 50*109/L), clinically significant active bleeding, active gastric ulcer disease, severe arterial hypertension, history of previous stroke; Inadequate renal function; creatinine clearance < 30 ml/min；
  4. Inadequate hepatic function: aminotransferase > 3 times the upper limit of normal (ULN) (if liver metastasis, alanine aminotransferase > 5 times the ULN
  5. Patients requiring strong cytochrome P450 3A4 (CYP3A4) inducers (rifampin, phenobarbital) or strong CYP3A4 inhibitors (HIV protease inhibitor, systemic ketoconazole) treatments.
  6. Plan of treatment with bevacizumab or other anti-cancer drugs known to increase the bleeding risk.
  7. Patients who have had anticoagulant drugs for any other reason.
  8. Women who are pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: rivaroxaban
oral Rivaroxaban 10mg per day for 90days
Drug: Rivaroxaban
Rivaroxaban 10mg orally per day for 90days
NO_INTERVENTION: blank control
mechanical prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of venous thrombosis
Time Frame: From date of randomization until the date of occurrence of thrombosis or date of death from any cause, whichever came first, assessed up to 6 months
detect the occurrence of venous thrombosis with ultrasound, venography if necessary.
From date of randomization until the date of occurrence of thrombosis or date of death from any cause, whichever came first, assessed up to 6 months
occurrence of a major bleeding event.
Time Frame: From date of randomization until the date of occurrence of a major bleeding event or date of death from any cause, whichever came first, assessed up to 6 months
define occurrence of major-bleeding event with ISTH standard
From date of randomization until the date of occurrence of a major bleeding event or date of death from any cause, whichever came first, assessed up to 6 months
occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event
Time Frame: From date of randomization until the date of occurrence of events or date of death from any cause, whichever came first, assessed up to 6 months
define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0
From date of randomization until the date of occurrence of events or date of death from any cause, whichever came first, assessed up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LiuZhou People's Hospital

Investigators

  • Study Chair: yu bin, PHD, Liuzhou people's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 8, 2020

Primary Completion (ANTICIPATED)

March 8, 2022

Study Completion (ANTICIPATED)

March 8, 2022

Study Registration Dates

First Submitted

March 8, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (ACTUAL)

March 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-1-2020-07-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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