Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters
NCT ID: NCT05029063
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1828 participants
INTERVENTIONAL
2022-10-05
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Experimental
Rivaroxaban 10mg OD
Rivaroxaban 10 MG
Identical comparator drug
Control
Identical Placebo 10mg OD
Rivaroxaban 10 MG
Identical comparator drug
Interventions
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Rivaroxaban 10 MG
Identical comparator drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Dr. Marc Carrier
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hospital Research Institute
Locations
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Nova Scotia Health
Halifax, Nova Scotia, Canada
William Osler Health System
Brampton, Ontario, Canada
HHS - Juravinski Hospital
Hamilton, Ontario, Canada
Ottawa Hospital Research Institute- The Ottawa Hospital
Ottawa, Ontario, Canada
Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
Niagara Health
St. Catharines, Ontario, Canada
Windsor Regional Hospital
Windsor, Ontario, Canada
CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE
Greenfield Park, Quebec, Canada
Centre Intégré de santé et de services sociaux de Chaudière-Appalaches
Lévis, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Ikesaka R, Siegal D, Mallick R, Wang TF, Witham D, Webb C, Carrier M; Canadian Venous Thromboembolism Research Network (CanVECTOR). Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM-Line): A two-center open-label pilot randomized controlled trial. Res Pract Thromb Haemost. 2021 May 5;5(4):e12517. doi: 10.1002/rth2.12517. eCollection 2021 May.
Other Identifiers
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TRIM-Line 3698
Identifier Type: -
Identifier Source: org_study_id
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