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Taking peoplePhase 3

Rivaroxaban to prevent blood clots in people with cancer and a central venous catheter

Tests low-dose rivaroxaban against blood clots in adults with cancer and central lines.

Key facts

Who runs it
Ottawa Hospital Research Institute
Where
Canada11 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters
Status
Recruiting
Phase
Phase 3
People taking part
1,828 people, planned
Started
5 Oct 2022
Expected to end
Dec 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Rivaroxaban 10 MG
Record updated
9 July 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with cancer who had a central venous catheter (a long-term IV line in a large vein) put in within the last 72 hours. It tests whether rivaroxaban, a blood thinner, prevents blood clots.

Age
18 years or older
Sex
All sexes
Disease stage
A new or existing diagnosis of cancer. People whose only cancer is basal cell or squamous cell skin cancer cannot join.
Earlier treatment
The catheter must have been put in within the last 72 hours. People who need blood thinners for other reasons cannot join.

Main reasons for not taking part

  • Catheter in place for more than 72 hours, or need for blood thinners for another reason
  • Major bleeding in the last 4 weeks, a long-term bleeding disorder, or other high bleeding risk
  • Severe kidney disease (creatinine clearance <30 mL/min), severe liver disease, or platelet count < 50x 109/L in the previous 3 months
  • Known pregnancy or plans to become pregnant in the next 3 months
  • Life expectancy under 3 months, allergy to rivaroxaban, or use of two antiplatelet drugs or strong CYP 3A4 and P-gp inhibitors

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours

Who cannot take part

  • Concomitant use of dual antiplatelet therapy
  • Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir)
  • Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
  • Major bleeding event in the last 4 weeks
  • Known allergy to rivaroxaban
  • History of condition at increased bleeding risk including, but not limited to:; cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the past 4 weeks; Chronic hemorrhagic disorder
  • Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin only
  • Severe renal insufficiency (Creatinine clearance <30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
  • Known thrombocytopenia (platelet count < 50x 109/L) in the previous 3 months
  • CVC in place for >72 hours
  • Patient requires anticoagulation for other indications
  • Known pregnancy or plan to become pregnant in next 3 months
  • Life expectancy <3 months
  • Refused or unable to obtain consent

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The purpose of the full trial is to determine the efficacy and safety of prophylactic dose rivaroxaban to prevent VTE among cancer patients with CVC.

The 2 groups in the trial

  • ExperimentalTreatment being tested

    Rivaroxaban 10mg OD

    Treatment: Rivaroxaban 10 MG

  • ControlPlacebo, for comparison

    Identical Placebo 10mg OD

    Treatment: Rivaroxaban 10 MG

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters: a Randomized Controlled Trial
Plain-language title
Rivaroxaban to prevent blood clots in people with cancer and a central venous catheterGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Publications
Record updated
9 July 2025