Your session is about to expire
← Back to Search
Anticoagulant
Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines (TRIM-Line Trial)
Phase 3
Waitlist Available
Led By Rick T Ikesaka, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
1.Patients 18 years of age or older with a new or existing diagnosis of cancer with a CVC inserted within the last 72 hours.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Approved for 20 Other Conditions
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved
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.
Eligible Conditions
- Deep Vein Thrombosis
- Catheter-related thrombosis
- Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Feasibility Outcome - Number of Participants Recruited Per Month
Secondary study objectives
Secondary Feasibility Outcomes - Percentage of Participants With Good Adherence to Therapy
Other study objectives
Number of Participants With CVC-Related Complication
Number of Participants With Clinically Relevant Non-Major Bleed
Number of Participants With Major Bleeding
+1 moreSide effects data
From 2020 Phase 3 trial • 105 Patients • NCT035068154%
Symptomatic Anemia
4%
Thrombocytopenia
4%
Pnemonia
2%
Urinary Tract Infection
2%
Nausea
2%
Herpes
2%
GERD
2%
Yeast Infection
2%
E-Coli, Urinary Tract Infection
2%
Neck Pain
2%
Syncope
2%
Dizziness
2%
Fever
2%
Shortness of Breath
2%
Chest Pain
2%
Neutropenia Enterocolitis
2%
Renal Failure
2%
Thrombocytosis
2%
Hydronephrosis
2%
Anemia
2%
Ulcer
2%
Chest pain
2%
Rash
2%
Chemotherapy Infusion Reaction
2%
Atrial Fibrillation
2%
Respiratory infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care
Rivaroxaban Thromboprophylaxis
Awards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Rivaroxaban ThromboprophylaxisExperimental Treatment1 Intervention
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.
Group II: Standard of careActive Control1 Intervention
No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban
FDA approved
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
577 Previous Clinical Trials
3,139,843 Total Patients Enrolled
11 Trials studying Deep Vein Thrombosis
4,089 Patients Enrolled for Deep Vein Thrombosis
Queen Elizabeth II Health Sciences CentreOTHER
25 Previous Clinical Trials
14,110 Total Patients Enrolled
University of AlbertaOTHER
942 Previous Clinical Trials
434,304 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
217 Patients Enrolled for Deep Vein Thrombosis
Hamilton Health Sciences CorporationOTHER
377 Previous Clinical Trials
339,824 Total Patients Enrolled
5 Trials studying Deep Vein Thrombosis
2,859 Patients Enrolled for Deep Vein Thrombosis
Rick T Ikesaka, MDPrincipal InvestigatorOttawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital