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Rivaroxaban for Preventing Blood Clots in Sickle Cell Disease (THIS Trial)

Phase 3
Recruiting
Research Sponsored by Kevin H.M. Kuo, MD, MSc, FRCPC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
New or pre-existing CVC planned for long term use (at least 6 months)
Adult (age 18 or older)
Must not have
Creatinine clearance <30mL/min (as calculated by Cockcroft-Gault equation[67])
Already on anticoagulation (prophylactic or therapeutic dose) for an indication other than CVC thromboprophylaxis
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 will assess the safety & feasibility of using rivaroxaban to prevent blood clots in adults with sickle cell disease who have a central venous catheter.

Who is the study for?
Adults over 18 with Sickle Cell Disease (SCD) who have or will get a Central Venous Catheter (CVC) intended for long-term use can join. They must be able to consent and not have conditions like recent blood clots, severe kidney issues, low platelets, extreme weight loss, uncontrolled high blood pressure, certain drug interactions, allergies to the study medication, or other serious health risks.
What is being tested?
The trial is testing if Rivaroxaban can prevent blood clots in adults with SCD who have CVCs. It's a pilot study where participants are randomly given either Rivaroxaban or a placebo daily for up to one year while their CVC is in place. The trial tracks enrollment rates and adherence to the medication regimen.
What are the potential side effects?
Potential side effects of Rivaroxaban may include bleeding complications since it's designed to prevent clotting. Other side effects could vary based on individual reactions but aren't specified here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have or will get a long-term central venous catheter.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is low, with a creatinine clearance under 30 mL/min.
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I am already taking blood thinners for a reason other than preventing clotting in a central venous catheter.
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I am not taking medications like ketoconazole or protease inhibitors.
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I am currently being treated for cancer, not including basal cell carcinoma.
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I am not taking medications like rifampin or St. John's wort.
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I am receiving care focused on relieving symptoms and improving quality of life.
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My high blood pressure is not controlled even with medication.
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I have active hepatitis.
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I weigh less than 40kg.
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My liver disease is severe, classified as Child-Pugh B or C.
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I am on strong blood thinner medication.

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.
Secondary study objectives
Estimate adherence to the study drug
Estimate participants compliance with study procedures, and lost to follow up
Other study objectives
Arterial thrombotic events
Bruising using a Likert scale
CVC change due to thrombosis or catheter occlusion not amenable to infusion of thrombolytics between study arms
+6 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: Rivaroxaban thromboprophylaxisExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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?

Kevin H.M. Kuo, MD, MSc, FRCPCLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
~15 spots leftby Nov 2025
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