Efficacy and Safety of Dabigatran in Patients With Cirrhosis and Portal Vein Thrombosis
NCT04433481 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2021-08-25
Summary
A randomized controlled trial to study the efficacy and safety of Dabigatran in Cirrhotic patients who develop PVT.In this study the patients who meet the inclusion criteria will be randomized to either receive Dabigatran or placebo \[multivitamin tablet\]. Blood samples will be taken \&Imaging will be done accordingly to notice progression or recanalization of PVT.The patients are followed up every 2 months up to 18 month .Then statistical analysis will be done to find whether the Dabigatran is efficacious in cirrhotic patients for recanalization of PVT.
Conditions
- Liver Cirrhosis
- Portal Vein Thrombosis
Interventions
- DRUG
-
Dabigatran
T. Dabigatran 150 mg twice a day
- OTHER
-
Placebo
placebo
Sponsors & Collaborators
-
Institute of Liver and Biliary Sciences, India
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-20
- Primary Completion
- 2022-05-31
- Completion
- 2022-05-31
Countries
- India
Study Locations
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