NCT05029063 Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters
| NCT ID | NCT05029063 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Venous Thromboembolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,828 participants |
| Start Date | 2022-10-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,828 participants in total. It began in 2022-10-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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
Contact & Investigator
Dr. Marc Carrier
PRINCIPAL INVESTIGATOR
Ottawa Hospital Research Institute
Frequently Asked Questions
Who can join the NCT05029063 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Thromboembolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05029063 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,828 participants.
Is NCT05029063 currently recruiting?
Yes, NCT05029063 is actively recruiting participants. Contact the research team at byazji@ohri.ca for enrollment information.
Where is the NCT05029063 trial being conducted?
This trial is being conducted at Halifax, Canada, Brampton, Canada, Hamilton, Canada, Ottawa, Canada and 7 additional locations.
Who is sponsoring the NCT05029063 clinical trial?
NCT05029063 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Dr. Marc Carrier at Ottawa Hospital Research Institute. The trial plans to enroll 1,828 participants.