Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

NCT05029063 | Recruiting Phase 3 DMC

• 1 other identifier: TRIM-Line 3698
• Study Type: interventional
• Target: 1,828
• Locations: 1 country
• Sites: 11

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.

Conditions

Venous Thromboembolism; Cancer

Outcome Measures

Primary Outcomes (2)

• Major VTE prevention

  Number of Major VTE's in patient population

  90 days (± 3 days) of randomization

• Episodes of Major Bleeding

  Number of participants who had a major bleed

  90 days (± 3 days) of randomization

Secondary Outcomes (17)

• Number of participants with Clinically Relevant Non-Major Bleeding (CRNMB)

  90 days (± 3 days) of randomization

• Number of patients who had a fatal VTE

  90 days (± 3 days) of randomization

• Number of patients who benefitted from using the experimental intervention

  90 days (± 3 days) of randomization

• PE

  90 days (± 3 days) of randomization

• Proximal CVC VTE

  90 days (± 3 days) of randomization

Study Arms (2)

Experimental

EXPERIMENTAL

Rivaroxaban 10mg OD

Drug: Rivaroxaban 10 MG

Control

PLACEBO COMPARATOR

Identical Placebo 10mg OD

Drug: Rivaroxaban 10 MG

Interventions

Rivaroxaban 10 MG DRUG

Identical comparator drug

Also known as: Placebo

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.

You may not qualify if:

• 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).
• Known pregnancy or plan to become pregnant in next 3 months
• Severe renal insufficiency (Creatinine clearance \<30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
• Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
• Known thrombocytopenia (platelet count \< 50x 109/L) in the previous 3 months
• Known allergy to rivaroxaban
• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (11)

Nova Scotia Health

Halifax, Nova Scotia, Canada

RECRUITING

William Osler Health System

Brampton, Ontario, L6R 3J7, Canada

RECRUITING

HHS - Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

Ottawa Hospital Research Institute- The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

RECRUITING

Sault Area Hospital

Sault Ste. Marie, Ontario, 750 Great Northern Rd., Canada

RECRUITING

Niagara Health

St. Catharines, Ontario, L2S0A9, Canada

RECRUITING

Windsor Regional Hospital

Windsor, Ontario, N8W 1L9, Canada

RECRUITING

CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE

Greenfield Park, Quebec, J4V 2H1, Canada

RECRUITING

Centre Intégré de santé et de services sociaux de Chaudière-Appalaches

Lévis, Quebec, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

McGill University Health Center

Montreal, Quebec, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 34027291 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism; Neoplasms

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dr. Marc Carrier

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bashour Yazji

CONTACT

613-737-8899; byazji@ohri.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind Randomized Control Trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 31, 2021
• Study Start: October 5, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (11)