Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome

• Status: Not yet recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: LEO Pharma; Sunnybrook Research Institute
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Rivaroxaban; Tinzaparin

Criteria

Inclusion Criteria:

1. 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)

Exclusion Criteria:

1. Age < 18 years

2. History of ipsilateral DVT (distal and/or proximal)

3. Active cancer

4. Thrombolysis or other invasive early thrombus removal technique to treat DVT or PE

5. Pregnant or breast feeding

6. Impaired renal function (creatinine clearance < 30 ml/min according to Cockcroft-Gault formula)

7. Concomitant use of drugs that interact with rivaroxaban (i.e. keto- or itraconazole, ritonavir)

8. Allergy or hypersensitivity to heparin or rivaroxaban, including heparin induced thrombocytopenia

9. Anticoagulant therapy contraindicated because of presence of active bleeding or condition with high risk of bleeding (e.g. peptic ulcer, other)

10. Thrombocytopenia (platelet count < 100 x 109/L)

11. Liver disease (including Child-Pugh Class B and Class C) associated with coagulopathy

12. Body weight > 120 kg or < 40 kg

13. Need for treatment with daily NSAIDs or antiplatelet agent (ibuprofen < 1200 mg/day, aspirin ≤ 160 mg/day or clopidogrel ≤ 75 mg/day are permitted)

14. Treatment with therapeutic doses of anticoagulants for > 48 hours (3 injections of LMWH if twice daily therapeutic LMWH used, 2 injections of LMWH if once daily therapeutic LMWH used, 3 doses of twice daily 15 mg of rivaroxaban)

15. Mechanical heart valve

16. Life expectancy < 1 year

17. Unable or unwilling to provide informed consent