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Clinical Trials in Canada / NCT05029063
Recruiting Phase 3

Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

NCT05029063 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2022-10-05
Last updated
2025-07-09

Condition(s) studied

Venous ThromboembolismCancer

Investigational drug(s) / intervention(s)

Rivaroxaban 10 MG →

Rivaroxaban 10 MG: Identical comparator drug

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
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 Recruiting

More Ottawa Hospital Research Institute trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05029063 on ClinicalTrials.gov ↗ ← All trials in Canada