Rivaroxaban for Cancer-related Blood Clot Prevention

(TRIM-Line Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Marc Carrier, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Dual antiplatelets, CYP 3A4 inhibitors

Disqualifiers: Pregnancy, Renal insufficiency, Liver disease, others

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain strong medications like cobicistat or ketoconazole, or if you need dual antiplatelet therapy.

What data supports the effectiveness of the drug Rivaroxaban for cancer-related blood clot prevention?

Research shows that Rivaroxaban, a drug used to prevent blood clots, is effective and safe for cancer patients with blood clot issues, similar to other treatments like low-molecular-weight heparins. It has been shown to prevent recurrent blood clots in cancer patients without increasing major bleeding risks. ^{1 2 3 4 5}

Is Rivaroxaban safe for humans?

Rivaroxaban, also known as Xarelto, has been studied in over 24,000 patients for various conditions, including cancer-related blood clots. It is generally considered safe, but bleeding is a known side effect, especially in patients with cancer. It offers benefits like once-daily dosing and fewer drug interactions compared to older treatments. ^{1 2 6 7 8}

How is the drug Rivaroxaban unique for preventing cancer-related blood clots?

Rivaroxaban is unique because it is an oral direct Factor Xa inhibitor that simplifies treatment by not requiring routine blood monitoring, unlike traditional vitamin K antagonists. It offers a convenient once-daily dosing and has fewer food and drug interactions, making it a potentially attractive alternative for preventing blood clots in cancer patients. ^{4 7 9 10 11}

Research Team

Marc Carrier, MD

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

This trial is for adults over 18 with any type of cancer who have had a central venous catheter (CVC) placed in the last 72 hours. It's not suitable for those with severe liver disease, low platelets, CVC older than 72 hours, other anticoagulation needs, recent major bleeding, pregnancy plans within three months, certain skin cancers only, life expectancy under three months or known allergies to rivaroxaban.

Inclusion Criteria

I am 18 or older with cancer and had a central venous catheter placed within the last 3 days.

Exclusion Criteria

Your platelet count has been very low in the past 3 months.

You are allergic to rivaroxaban.

You are not expected to live for more than 3 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either rivaroxaban 10mg daily or placebo for the prevention of VTE

90 days

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Rivaroxaban (Anticoagulant)

Trial Overview The trial tests if a blood thinner called Rivaroxaban can prevent blood clots in cancer patients who have a CVC. The goal is to see how effective and safe this medication is at stopping clots from forming without causing too many side effects.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

Rivaroxaban 10mg OD

Group II: Control Placebo Group 1 Intervention

Identical Placebo 10mg OD

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ottawa Hospital Research Institute- The Ottawa Hospital Ottawa, Canada

HHS - Juravinski Hospital Hamilton, Canada

Niagara Health St. Catharines, Canada

Windsor Regional Hospital Windsor, Canada

More Trial Locations

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Patients Recruited

3,283,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Rivaroxaban for the Treatment of Symptomatic Venous Thromboembolism in 400 Patients With Active Cancer: A Single-Center Experience. Pignataro, BS., Nishinari, K., Cavalcante, RN., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of bleeding incidences associated with rivaroxaban therapy in adults with solid tumors. Weddle, KJ., Kiel, PJ., Patel, PJ.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective comparison of low molecular weight heparin vs. warfarin vs. oral Xa inhibitors for the prevention of recurrent venous thromboembolism in oncology patients: The Re-CLOT study. Alzghari, SK., Seago, SE., Garza, JE., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivaroxaban compared to no treatment in ER-negative stage I-III early breast cancer patients (the TIP Trial): study protocol for a phase II preoperative window-of-opportunity study design randomised controlled trial. Castle, J., Blower, E., Bundred, NJ., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Venous thromboembolic complications in oncological patients: present-day possibilities of effective and safe anticoagulant therapy]. Fokin, AA., Bagaev, KV.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy: A Single-Center Registry. Bott-Kitslaar, DM., Saadiq, RA., McBane, RD., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral direct factor Xa inhibitors, with special emphasis on rivaroxaban. Mousa, SA.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of rivaroxaban in patients with venous thromboembolism and active cancer: A subanalysis of the J'xactly study. Hisatake, S., Ikeda, T., Fukuda, I., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivaroxaban, an oral direct factor Xa inhibitor. Piccini, JP., Patel, MR., Mahaffey, KW., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivaroxaban. A novel, oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic disorders. Perzborn, E., Kubitza, D., Misselwitz, F.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rivaroxaban in the prevention and treatment of thromboembolic disorders]. Helbing, T., Bode, C., Moser, M.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Oral Rivaroxaban for the Treatment of Symptomatic Venous Thromboembolism in 400 Patients With Active Cancer: A Single-Center Experience. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Assessment of bleeding incidences associated with rivaroxaban therapy in adults with solid tumors. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Retrospective comparison of low molecular weight heparin vs. warfarin vs. oral Xa inhibitors for the prevention of recurrent venous thromboembolism in oncology patients: The Re-CLOT study. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Rivaroxaban compared to no treatment in ER-negative stage I-III early breast cancer patients (the TIP Trial): study protocol for a phase II preoperative window-of-opportunity study design randomised controlled trial. [2021]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Venous thromboembolic complications in oncological patients: present-day possibilities of effective and safe anticoagulant therapy]. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy: A Single-Center Registry. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Oral direct factor Xa inhibitors, with special emphasis on rivaroxaban. [2015]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of rivaroxaban in patients with venous thromboembolism and active cancer: A subanalysis of the J'xactly study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Rivaroxaban, an oral direct factor Xa inhibitor. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Rivaroxaban. A novel, oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic disorders. [2015]

11. Germany pubmed.ncbi.nlm.nih.gov

[Rivaroxaban in the prevention and treatment of thromboembolic disorders]. [2015]