Status:
TERMINATED
Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
LEO Pharma
Sunnybrook Research Institute
Conditions:
Deep Vein Thrombosis
Post Thrombotic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
The TILE pilot study will investigate the magnitude of difference in effectiveness between LMWH (low molecular weight heparin, tinzaparin) plus DOAC (Direct Oral Anticoagulants, rivaroxaban) vs. DOAC ...
Eligibility Criteria
Inclusion
- 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
- 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
- Anticoagulant therapy contraindicated because of presence of active bleeding or condition with high risk of bleeding (e.g. peptic ulcer, acute or subacute septic endocarditis, uncontrolled severe hypertension, other)
- Thrombocytopenia (platelet count \< 100 x 109/L)
- Liver disease (including Child-Pugh Class B and Class C) associated with coagulopathy
- Body weight \> 120 kg or \< 40 kg
- Need for treatment with daily NSAIDs or antiplatelet agent (ibuprofen \< 1200 mg/day, aspirin ≤ 160 mg/day or clopidogrel ≤ 75 mg/day are permitted)
- Treatment with therapeutic doses of anticoagulants for \> 72 hours
- Mechanical heart valve
- Antiphospholipid syndrome
- Sulphite sensitivity
- Lactose sensitivity
- Life expectancy \< 1 year
- Unable or unwilling to provide informed consent
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04794569
Start Date
November 15 2021
End Date
January 19 2024
Last Update
April 4 2024
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
2
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3
3
Sir Mortimer B. Davis Jewish General Hospital
Montréal, Ontario, Canada, H3T 1E2
4
The Ottawa Hospital - Ottawa Hospital Research Institute (OHRI)
Ottawa, Ontario, Canada