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Nadroparin-Warfarin Sequential Anticoagulation in PVT
NCT04173429Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2017
- Primary completion
- Jan 2020
- Countries
- 1
- Sponsor
- Qilu Hospital of Shandong University
- Modality
- Recombinant Proteins and Enzymes, Small Molecules
- Drugs
- nadroparinwarfarin
- Conditions
- portal vein thrombosis (PVT)
01
Overview
Phase 4, randomised, open-label trial of nadroparin and warfarin in portal vein thrombosis (PVT) (2 arms), sponsored by Qilu Hospital of Shandong University. Primary endpoint: Recanalization Rate at 6 months. Started Jan 2017; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Nadroparin-Warfarin Sequential Therapy
Nadroparin calcium SC for 1 month followed by Warfarin oral for 5 months
Control Group
No anticoagulation therapy
03
Who it enrols
Adult patients aged 18-75 with liver cirrhosis and portal vein thrombosis, excluding those with cavernous transformation, active bleeding, severe thrombocytopenia, renal failure, or prior antithrombotic treatment.
04
Endpoints
Primary
Recanalization Rate
Secondary
Rate of Bleeding
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