Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines

NCT03506815 | Completed Phase 3 Results DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the Pilot Trial: To determine the feasibility of conducting a multicentre randomized open label controlled trial evaluating the use of prophylactic dose rivaroxaban to prevent central venous catheter (CVC) associated venous thromboembolism (VTE) among cancer patients. Hypothesis: treatment with low dose rivaroxaban (10mg) will reduce the incidence of upper extremity venous thrombosis in a high risk population with cancer and CVC.

Conditions

Upper Extremity Deep Vein Thrombosis; Central Venous Catheter Thrombosis; Cancer

Keywords

Upper Extremity Deep Vein Thrombosis; Thromboprophylaxis; Cancer; Randomized Trial

Outcome Measures

Primary Outcomes (1)

• Primary Feasibility Outcome - Number of Participants Recruited Per Month

  A convenience sample size of 100 patients was chosen to allow reporting of the average monthly recruitment.

  12 months

Secondary Outcomes (1)

• Secondary Feasibility Outcomes - Percentage of Participants With Good Adherence to Therapy

  90 days

Other Outcomes (4)

• Number of Participants With Thrombotic Complication

  90 days

• Number of Participants With CVC-Related Complication

  90 days

• Number of Participants With Major Bleeding

  90 days

Study Arms (2)

Rivaroxaban Thromboprophylaxis

EXPERIMENTAL

Rivaroxaban 10 mg po daily for 90 days(+/- 3 days). After the Day - 90 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.

Drug: Rivaroxaban 10 MG

Standard of care

NO INTERVENTION

No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.

Interventions

Rivaroxaban 10 MG DRUG

Rivaroxaban 10mg po daily x 90 (+/- 3 days)

Also known as: Xarelto 10mg tablet po daily

Rivaroxaban Thromboprophylaxis

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 with a CVC inserted within the last 72 hours.

You may not qualify if:

• CVC in place for \>72 hours
• Patient requires anticoagulation for other indication
• Concomitant use of dual antiplatelet therapy
• Prior VTE
• Major bleeding event in the last 6 weeks
• Patient on concomitant medication with known interaction with rivaroxaban (eg. CYP3A4 inhibitor)
• Pregnancy (documentation of use of effective contraception if sexually active or negative B-Hcg required)
• Known renal failure, based on Creatinine clearance \<30 mL/min (Cockcroft-Gault) (in the previous 3 months)
• Documented severe liver disease (eg. acute clinical hepatitis, chronic active hepatitis, cirrhosis or ALT \>3ULN) ( in the previous 3 months)
• Known thrombocytopenia \< 50x 109/L (in the previous 3 months)
• Allergy to rivaroxaban
• Life expectancy \<6 months
• History of condition at increased bleeding risk including, but not limited to:
• Major surgical procedure or trauma within 30 days before the randomization visit
• Clinically significant gastrointestinal bleeding within 6 months before the randomization visit

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Queen Elizabeth II Health Sciences Centre: collaborator
• University of Alberta: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

The Ottawa Hospital General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

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 RESULT

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis; Neoplasms

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

A PROBE design was chosen in order to be pragmatic and to reflect standard clinical practice, which could make the results more easily applicable to routine medical care. The study was designed to assess feasibility and not to determine differences in the risk of clinical events between treatment groups. As a result, the number of clinical outcome events was relatively small, leading to imprecision and wide confidence intervals.

Results Point of Contact

• Title: Dr. Marc Carrier
• Organization: The Ottawa Hospital

mcarrier@toh.ca

613-737-8899

Study Officials

• Rick T Ikesaka, MD

  Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Pilot Trial comparing two groups - Rivaroxaban 10mg po daily for 90 days vs standard of care (usual treatment)

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 24, 2018
• Study Start: March 15, 2019
• Primary Completion: May 14, 2020
• Study Completion: June 14, 2020
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)