Recruiting
Phase 3

Observational Study

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05029063

Conditions

Venous Thromboembolism

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rivaroxaban 10 MG

Study Details

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

Study ID

NCT05029063

Start date

Oct 5, 2022

Status verified date

Jul, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1828 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Experimental

Rivaroxaban 10mg OD

placebo comparator: Control

Identical Placebo 10mg OD

Interventions

Rivaroxaban 10 MG

Identical comparator drug

Primary outcome measure

  • Major VTE prevention [ Time Frame: 90 days (± 3 days) of randomization ]
  • Episodes of Major Bleeding [ Time Frame: 90 days (± 3 days) of randomization ]

Central Contacts and Locations

Central contacts

Locations

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada

William Osler Health System

Recruiting

Brampton, Ontario, Canada, L6R 3J7

HHS - Juravinski Hospital

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

Ottawa Hospital Research Institute- The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Contacts

Principal Investigator:

Marc Carrier, Dr

Sault Area Hospital

Recruiting

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

Niagara Health

Recruiting

St. Catharines, Ontario, Canada, L2S0A9

Windsor Regional Hospital

Recruiting

Windsor, Ontario, Canada, N8W 1L9

CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

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

Recruiting

Lévis, Quebec, Canada

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

McGill University Health Center

Recruiting

Montreal, Quebec, Canada

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jul 9, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-07-09.