Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT05029063
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cancer
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rivaroxaban 10 MG — DRUG
    Identical comparator drug

Study Details

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.

Key Dates

First listed
Aug 31, 2021
Start date
Oct 5, 2022
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
1,828 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Experimental
    Rivaroxaban 10mg OD
  • Placebo Comparator: Control
    Identical Placebo 10mg OD

Primary Outcome Measure

Major VTE prevention [ Time Frame: 90 days (± 3 days) of randomization ]

Central Contacts

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