Rivaroxaban for Cancer-related Blood Clot Prevention
(TRIM-Line Trial)
Recruiting in Palo Alto (17 mi)
+6 other locations
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.
12345Is 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.
12678How 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.
4791011Eligibility 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.
+12 more
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Rivaroxaban 10mg OD
Group II: ControlPlacebo Group1 Intervention
Identical Placebo 10mg OD
Rivaroxaban is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Xarelto for:
- 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
🇪🇺 Approved in European Union as Xarelto for:
- 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
Research Locations NearbySelect from list below to view details:
Ottawa Hospital Research Institute- The Ottawa HospitalOttawa, Canada
HHS - Juravinski HospitalHamilton, Canada
Niagara HealthSt. Catharines, Canada
Windsor Regional HospitalWindsor, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Ottawa Hospital Research InstituteLead Sponsor
References
Oral Rivaroxaban for the Treatment of Symptomatic Venous Thromboembolism in 400 Patients With Active Cancer: A Single-Center Experience. [2018]To study the safety and efficacy of rivaroxaban-a direct oral anticoagulant-use in patients with active cancer and venous thromboembolism (VTE).
Assessment of bleeding incidences associated with rivaroxaban therapy in adults with solid tumors. [2019]Report bleeding incidences associated with rivaroxaban in adult patients with solid tumor malignancies requiring anticoagulation therapy.
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]Background There is increasing evidence indicating oral factor Xa inhibitors can be used for secondary prevention of venous thromboembolism. Studies are needed to compare oral factor Xa inhibitors, low molecular weight heparins, and warfarin in the oncology population. The purpose of this study is to evaluate the recurrent venous thromboembolism incidence in oncology patients utilizing oral Xa inhibitors, low molecular weight heparins, or warfarin. Methods Using retrospectively collected data, we compared the recurrent venous thromboembolism incidence in oncology patients taking rivaroxaban/apixaban, enoxaparin, or warfarin with at least three months of follow-up. Patients were included if they had an active cancer, venous thromboembolism, and taking warfarin, enoxaparin, or rivaroxaban/apixaban. The primary endpoint was the first episode of recurrent venous thromboembolism at three months. Secondary endpoints included recurrent venous thromboembolism after six months, major bleeding, and mortality. Results Of 127 venous thromboembolism patients, 48 received rivaroxaban or apixaban, 23 received enoxaparin, and 56 received warfarin. The three most common cancer diagnoses were lung (21%), colorectal (14%), and breast (14%). There was no difference in venous thromboembolism recurrence at three months between the rivaroxaban/apixaban (0%), warfarin (3.6%), and the enoxaparin cohorts (4.4%) (p = 0.8319). Major bleeding at three months was only seen in one patient in the enoxaparin arm (4.2%). Mortality at three months was 0%, 3.6%, and 17.4% in the rivaroxaban/apixaban, warfarin, and enoxaparin cohorts, respectively. Conclusion The results of this retrospective study suggest that oral factor Xa inhibitors are potential options for cancer patients with venous thromboembolism. However, randomized, controlled trials are needed to confirm these results.
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]Breast cancer patients are at a four-fold increased risk of developing a venous thromboembolism (VTE), a major cause of death in this group. Conversely, coagulation factors promote tumour growth and metastasis. This has been evidenced in preclinical models, with an inhibitory effect of anticoagulants on cancer growth through proliferative, angiogenic, apoptotic, cancer stem cell and metastatic processes. The extrinsic clotting pathway is also more upregulated in patients in the relatively poorer prognosis oestrogen receptor (ER)-negative breast cancer subgroup, with increased tumour stromal expression of the coagulation factors Tissue Factor and thrombin. Rivaroxaban (Xarelto®, Bayer AG, Leverkusen, Germany) is a direct oral anticoagulant (DOAC). It is a Factor Xa inhibitor that is routinely prescribed for the prevention of stroke in non-valvular atrial fibrillation and for both VTE prophylaxis and treatment. This trial will assess the anti-proliferative and other anti-cancer progression mechanisms of Rivaroxaban in ER-negative early breast cancer patients.
[Venous thromboembolic complications in oncological patients: present-day possibilities of effective and safe anticoagulant therapy]. [2020]Cancer-associated thromboembolic complications in malignant neoplasms are commonly encountered. They deteriorate the course of the underlying disease and are frequent causes of death. The oncological patient is at high risk of not only thrombosis but haemorrhage during anticoagulant therapy. Recent randomized clinical trials have positively appreciated the possibilities of direct oral anticoagulants in treatment and prevention of thromboses in oncological patients. Analysing subgroups in these studies demonstrated that direct oral anticoagulants during long-term administration were at least as effective and safe as vitamin K antagonists. The most significant by the number of cases, duration of therapy, and methodology of analysis are the reports regarding rivaroxaban - an oral, direct factor Xa inhibitor. There are also findings obtained in a separate randomized study, confirming efficacy and safety of rivaroxaban in treatment of patients with cancer-associated venous thromboembolic complications as compared with therapy with low-molecular-weight heparins. Namely these results formed the basis for the guidelines of the International Society on Thrombosis and Hemostasis (SSC ISTH), according to which rivaroxaban may be regarded as an alternative to low-molecular-weight heparins in certain clinical situations.
Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy: A Single-Center Registry. [2022]The purpose of this study is to evaluate the efficacy and safety of rivaroxaban in patients with venous thromboembolism and active malignancy, given the paucity of clinical data with the use of direct Xa inhibitors in this high-risk population.
Oral direct factor Xa inhibitors, with special emphasis on rivaroxaban. [2015]Rivaroxaban is a small-molecule, direct factor Xa inhibitor that is under investigation for the prevention and treatment of venous and arterial thrombosis. To date, oral anticoagulants have been limited largely to vitamin K antagonists. Despite their remarkable benefits, vitamin K antagonists are limited by their narrow therapeutic window, the existence of multiple food and drug interactions, and the need for frequent monitoring and dose-adjustment. Rivaroxaban represents a potentially attractive alternative to warfarin, as it could enable simplified once-daily dosing, requires no therapeutic monitoring, and has a lower potential for drug interactions. At present, the safety and efficacy of rivaroxaban for the prophylaxis and treatment of venous thromboembolism has been evaluated in phase-II and phase-III trials involving over 24,000 patients. Rivaroxaban is also being evaluated for the treatment of pulmonary embolism, secondary prevention after acute coronary syndromes, and the prevention of stroke and non-central nervous system embolism in patients with non-valvular atrial fibrillation. The need for new oral anticoagulants, the development and pharmacology of rivaroxaban, results of completed studies of rivaroxaban, and details of ongoing phase-II and phase-III trials with rivaroxaban are the subjects of this chapter.
Effectiveness and safety of rivaroxaban in patients with venous thromboembolism and active cancer: A subanalysis of the J'xactly study. [2023]Data on the effectiveness and safety of rivaroxaban for the treatment of patients with venous thromboembolism (VTE) and active cancer are limited in the Japanese real-world setting.
Rivaroxaban, an oral direct factor Xa inhibitor. [2019]Rivaroxaban is a small molecule, direct Factor Xa inhibitor and may be a potentially attractive alternative to vitamin K antagonists. Rivaroxaban is being investigated for the prevention and treatment of venous and arterial thrombosis. A broad search of Medline, clinicaltrials.gov and the annual proceedings of the American Society of Hematology and the International Society on Thrombosis and Hemostasis was conducted. This review addresses the findings of this systematic search, including the need for new oral anticoagulants, the development and pharmacology of rivaroxaban, and the results of completed as well as ongoing trials with rivaroxaban. At present, the safety and efficacy of rivaroxaban for the prophylaxis and treatment of venous thromboembolism has been evaluated in Phase II and Phase III trials involving over 24,000 patients. Additionally, rivaroxaban is being evaluated for the treatment of pulmonary embolism, secondary prevention after acute coronary syndromes and the prevention of stroke and non-central nervous system embolism in patients with non-valvular atrial fibrillation. The drug may have its greatest impact in providing a much-needed and attractive alternative to warfarin. Further data (especially large Phase III trials) are required.
Rivaroxaban. A novel, oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic disorders. [2015]Rivaroxaban (Xarelto) is a novel, oral, direct Factor Xa (FXa) inhibitor in late-stage development for the prevention and treatment of thromboembolic disorders. Rivaroxaban inhibits clot-associated and free FXa activity, and prothrombinase activity, and reduces thrombin generation. In animal models, rivaroxaban prevented venous and arterial thrombosis, and was effective at treating venous thrombosis. Rivaroxaban has high oral bioavailability, a rapid onset of action and predictable pharmacokinetics. In phase II studies, rivaroxaban was effective and well tolerated for the prevention of venous thromboembolism (VTE) after major orthopaedic surgery, and for the treatment of deep vein thrombosis. In a phase III study, rivaroxaban demonstrated significantly superior efficacy to enoxaparin for thromboprophylaxis after total knee arthroplasty, with similar low bleeding. Rivaroxaban is also being assessed for the treatment and secondary prevention of VTE, prevention of stroke in patients with atrial fibrillation and secondary prevention in patients with acute coronary syndrome. Rivaroxaban is a promising alternative to current pharmacological agents for thromboembolic disorders.
[Rivaroxaban in the prevention and treatment of thromboembolic disorders]. [2015]Rivaroxaban (Xarelto(®)) is a new anticoagulant for the prevention and treatment of thromboembolic disorders. Rivaroxaban inhibits coagulation factor Xa directly, has high oral bioavailability, shows low propensity for drug-drug interactions and requires no routine coagulation monitoring. In patients undergoing elective knee or hip replacement surgery rivaroxaban (10 mg/d) is highly effective to prevent venous thromboembolism. In patients with non-valvular atrial fibrillation rivaroxaban (20 mg/d) has been approved to prevent stroke or systemic embolism. The favourable benefit-risk profile of rivaroxaban in the treatment of deep vein thrombosis (DVT) was shown in EINSTEIN-DVT and led to its clinical approval (twice daily 15 mg for 3 weeks, followed by 20 mg/d). Based on ATLAS-ACS-TIMI-51 which has shown that rivaroxaban (2.5 mg twice daily) reduced thrombotic cardiovascular events and mortality in patients with a recent acute coronary syndrome, the approval of low dose rivaroxaban has been submitted for this indication. Taken together, rivaroxaban may become an effective alternative to standard anticoagulants in the prevention and treatment of thromboembolic disorders.