Testing Rivaroxaban against a placebo for venous thromboembolism
Official title: Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters
Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters: a Randomized Controlled Trial
- Phase 3
- 2 groups
- Sites in Halifax, Brampton and 8 more cities
- Recruiting
Interventions
- Medication
Rivaroxaban 10 MG
Identical comparator drug
Canadian Sites (11)
11 of 11 recruiting
- Recruiting
Nova Scotia Health
Halifax, Nova Scotia
- Recruiting
William Osler Health System
Brampton, Ontario
- Recruiting
HHS - Juravinski Hospital
Hamilton, Ontario
- Recruiting
Ottawa Hospital Research Institute- The Ottawa Hospital
Ottawa, Ontario
- Recruiting
Sault Area Hospital
Sault Ste. Marie, Ontario
- Recruiting
Niagara Health
St. Catharines, Ontario
- Recruiting
Windsor Regional Hospital
Windsor, Ontario
- Recruiting
CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE
Greenfield Park, Quebec
- Recruiting
Centre Intégré de santé et de services sociaux de Chaudière-Appalaches
Lévis, Quebec
- Recruiting
Jewish General Hospital
Montreal, Quebec
- Recruiting
McGill University Health Center
Montreal, Quebec
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.
Exclusion
- −Known allergy to rivaroxaban
- −Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
- −CVC in place for \>72 hours
- −Patient requires anticoagulation for other indications
- −Concomitant use of dual antiplatelet therapy
- −Major bleeding event in the last 4 weeks
- −Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir).
- −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
- −Life expectancy \<3 months
- −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
- −Refused or unable to obtain consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Known pregnancy or plan to become pregnant in next 3 months
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Rivaroxaban 10 MG.
Registry label: A: Experimental
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Rivaroxaban 10 MG.
Registry label: B: Control
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,828 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: 90 days (± 3 days) of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Major VTE prevention — measured over 90 days (± 3 days) of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
Episodes of Major Bleeding — measured over 90 days (± 3 days) of randomization.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05029063 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Rivaroxaban 10 MGDrug
Identical comparator drug
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 90 days (± 3 days) of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
The study as a whole is currently expected to finish around 2027-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,828 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 10 locations, including: Halifax, Nova Scotia, Canada; Brampton, Ontario, Canada; Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Sault Ste. Marie, Ontario, Canada; St. Catharines, Ontario, Canada, and 4 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.