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Anticoagulant

Tinzaparin + Rivaroxaban for Post-Thrombotic Syndrome (TILE Trial)

Phase 4

Waitlist Available

Led By Jean-Philippe Galanaud, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with objectively confirmed acute (i.e. onset of symptoms <10 days) symptomatic iliac or common femoral DVT (DVT diagnosis will be made with a Compression Ultrasound (CUS) according to standardized consensus criteria)

Be older than 18 years old

Must not have

Treatment with therapeutic doses of anticoagulants for > 72 hours

Active cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three time points: at 3 weeks and at 6 months post randomization

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if using two blood thinners together is better than one for preventing complications after a serious leg blood clot. It targets patients at high risk for long-term issues and works by thinning the blood and reducing inflammation.

Who is the study for?

This trial is for adults with a recent diagnosis of iliac or common femoral deep vein thrombosis confirmed by ultrasound. It's not for pregnant or breastfeeding individuals, those under 18, people with impaired kidney function, active cancer, certain drug sensitivities including lactose and sulphite, liver disease with coagulopathy, extreme body weights, or anyone on conflicting medications.

What is being tested?

The TILE study compares two treatments to prevent post-thrombotic syndrome in patients with deep vein thrombosis: extended use of tinzaparin (a type of heparin) versus rivaroxaban (an oral anticoagulant). Participants are randomly assigned to one treatment group in this open-label trial where outcomes are assessed blindly.

What are the potential side effects?

Potential side effects include bleeding risks due to the blood-thinning nature of both tinzaparin and rivaroxaban. There may also be allergic reactions to the drugs' components. Kidney function might be affected by rivaroxaban in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a recent blood clot in my leg confirmed by an ultrasound.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been on blood thinners for more than 3 days.

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My cancer is currently active.

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I am not taking medications like ketoconazole or ritonavir.

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I cannot take blood thinners due to active bleeding or a high risk of bleeding.

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I have had a clot removed with medication or a procedure.

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I have liver disease with blood clotting problems.

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I am under 18 years old.

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I have had a blood clot in the same side of my body before.

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I take low-dose NSAIDs or antiplatelet drugs daily.

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My kidney function is reduced with a creatinine clearance below 30 ml/min.

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My body weight is either above 120 kg or below 40 kg.

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I have been diagnosed with antiphospholipid syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three time points: at 3 weeks and at 6 months post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three time points: at 3 weeks and at 6 months post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and three time points: at 3 weeks and at 6 months post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Main feasibility

PTS at 6 months

Secondary study objectives

DVT-related leg pain

Global Improvement

PTS severity

+6 more

Other study objectives

Health Services Research Issues

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TinzaparinExperimental Treatment1 Intervention

initial 3-week lead-in course of low molecular weight heparin (tinzaparin 175 units/Kg sc daily) followed by a direct oral anticoagulant (rivaroxaban 20mg po daily) for at least 3 months

Group II: RivaroxabanActive Control1 Intervention

Direct oral anticoagulant only (rivaroxaban 15mg po BID for 3 weeks followed by rivaroxaban 20mg po daily ) for at least 3 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

tinzaparin

2005

Completed Phase 4

~400

0 / 13Eligibility criteria met