TerminatedPhase 4

Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome

Stopped: funding discontinued

Canada9 participantsStarted 2021-11-15

Plain-language summary

The TILE pilot study will be a multicenter, open-label, assessor-blinded RCT (randomized control trial) comparing extended LMWH (Low Molecular Weight Heparin) vs. DOAC (Direct Oral Anticoagulants) to PTS (prevent post thrombotic syndrome) in patients with DVT (Deep Vein Thrombosis).

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Age \< 18 years
✕. History of ipsilateral DVT (distal and/or proximal)
✕. Active cancer
✕. Thrombolysis or other invasive early thrombus removal technique to treat DVT or PE
✕. Pregnant or breast feeding
✕. Impaired renal function (creatinine clearance \< 30 ml/min according to Cockcroft-Gault formula)
✕. Concomitant use of drugs that interact with rivaroxaban (i.e. keto- or itraconazole, ritonavir)
✕. Allergy or hypersensitivity to heparin or rivaroxaban, including heparin induced thrombocytopenia

What they're measuring

PTS at 6 months

Timeframe: 6 months post randomization

Main feasibility

Timeframe: 3 months post randomization

Trial details

NCT IDNCT04794569

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-19

View on ClinicalTrials.gov More Deep Vein Thrombosis trials