Rivaroxaban for Cancer-related Blood Clot Prevention
(TRIM-Line Trial)
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.12345
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.12678
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.4791011
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either rivaroxaban 10mg daily or placebo for the prevention of VTE
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Rivaroxaban (Anticoagulant)
Rivaroxaban is already approved in United States, European Union for the following indications:
- Deep vein thrombosis (DVT)
- Venous thromboembolism (VTE)
- Stroke prevention in non-valvular atrial fibrillation
- Prevention of VTE in patients undergoing knee or hip replacement surgery
- Deep vein thrombosis (DVT)
- Venous thromboembolism (VTE)
- Stroke prevention in non-valvular atrial fibrillation
- Prevention of VTE in patients undergoing knee or hip replacement surgery
- Prevention of atherothrombotic events in patients with acute coronary syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Hospital Research Institute
Lead Sponsor