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

Palo Alto (17 mi)

Overseen byJean-Philippe Galanaud, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

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

My cancer is currently active.

I am not taking medications like ketoconazole or ritonavir.

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

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

I have liver disease with blood clotting problems.

I am under 18 years old.

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

I take low-dose NSAIDs or antiplatelet drugs daily.

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

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

I have been diagnosed with antiphospholipid syndrome.

Treatment Details

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.

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

Rivaroxaban is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Xarelto for: