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Anticoagulant

Rivaroxaban for Cancer-related Blood Clot Prevention (TRIM-Line Trial)

Phase 3
Recruiting
Led By Dr. Marc Carrier
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
Be older than 18 years old
Must not have
Concomitant use of dual antiplatelet therapy
Patient requires anticoagulation for other indications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Approved for 20 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial

Summary

This trial is testing if a drug can prevent blood clots in cancer patients with a central venous catheter.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Rivaroxaban may cause bleeding problems since it's designed to prevent clotting. This could range from minor bruising to more serious internal bleeds. There might also be risks of allergic reactions or liver issues due to the medication.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking two medications to prevent blood clots.
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I need blood thinners for a health condition.
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I have a condition that increases my risk of bleeding, such as recent stroke or active ulcers.
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My kidney function is severely reduced.
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I have not had a major bleeding event in the last 4 weeks.
Select...
I have a long-term bleeding disorder.
Select...
I am not taking medications like cobicistat or ketoconazole.
Select...
My cancer is either basal cell or squamous cell skin cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Episodes of Major Bleeding
Major VTE prevention
Secondary study objectives
CVC Life-span
Distal CVC VTE
Distal Lower extremity DVT
+14 more

Side effects data

From 2020 Phase 3 trial • 105 Patients • NCT03506815
4%
Pnemonia
4%
Thrombocytopenia
4%
Symptomatic Anemia
2%
Urinary Tract Infection
2%
Chest pain
2%
Herpes
2%
Yeast Infection
2%
GERD
2%
Rash
2%
Atrial Fibrillation
2%
Neck Pain
2%
Syncope
2%
Chest Pain
2%
Dizziness
2%
Fever
2%
Shortness of Breath
2%
Neutropenia Enterocolitis
2%
Nausea
2%
Renal Failure
2%
Ulcer
2%
Thrombocytosis
2%
E-Coli, Urinary Tract Infection
2%
Anemia
2%
Chemotherapy Infusion Reaction
2%
Hydronephrosis
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.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Rivaroxaban 10mg OD
Group II: ControlPlacebo Group1 Intervention
Identical Placebo 10mg OD
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
575 Previous Clinical Trials
3,093,072 Total Patients Enrolled
11 Trials studying Deep Vein Thrombosis
4,089 Patients Enrolled for Deep Vein Thrombosis
Dr. Marc CarrierPrincipal InvestigatorOttawa Hospital Research Institute

Media Library

Rivaroxaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT05029063 — Phase 3
Deep Vein Thrombosis Research Study Groups: Control, Experimental
Deep Vein Thrombosis Clinical Trial 2023: Rivaroxaban Highlights & Side Effects. Trial Name: NCT05029063 — Phase 3
Rivaroxaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05029063 — Phase 3
~895 spots leftby Dec 2026
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