Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
1,828 (estimated)
Sponsor
Ottawa Hospital Research Institute · Other
Who this trial is looking for
This trial is looking for cancer patients who have a central venous catheter (CVC) recently placed. Participants will take a medication called rivaroxaban to see if it helps prevent blood clots.
Are You a Good Fit for This Trial?
Rules you outSevere liver diseaseThrombocytopenia
You may be able to join if
I am 18 years old or older
I have a new or existing diagnosis of cancer
I have a CVC that was placed in the last 72 hours
You may not be able to join if
My CVC has been in place for more than 72 hours
I need anticoagulation for other reasons
I have had a major bleeding event in the last 4 weeks
I have a severe kidney problem
I am pregnant or planning to become pregnant in the next 3 months
I have a known allergy to rivaroxaban
My life expectancy is less than 3 months
I have a history of severe bleeding risk conditions
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed 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.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 criteria:
1. CVC in place for \>72 hours
2. Patient requires anticoagulation for other indications
3. Concomitant use of dual antiplatelet therapy
…
Inclusion Criteria:
* 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 criteria:
1. CVC in place for \>72 hours
2. Patient requires anticoagulation for other indications
3. Concomitant use of dual antiplatelet therapy
4. Major bleeding event in the last 4 weeks
5. Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir).
6. Known pregnancy or plan to become pregnant in next 3 months
7. Severe renal insufficiency (Creatinine clearance \<30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
8. Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
9. Known thrombocytopenia (platelet count \< 50x 109/L) in the previous 3 months
10. Known allergy to rivaroxaban
11. Life expectancy \<3 months
12. History of condition at increased bleeding risk including, but not limited to:
1. cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the past 4 weeks.
2. Chronic hemorrhagic disorder
13. Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin only
14. Refused or unable to obtain consent
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