Efficacy and Safety of Acenocoumarol for Treatment of Nontumor Portal Vein Thrombosis in Cirrhosis of Liver

Portal Vein Thrombosis Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01631877
• Other study ID #: ILBS- PVT-01
• Status: Withdrawn
• Phase: N/A
• Start date: June 2012
• Est. completion date: June 1, 2017

Study information

• Verified date: December 2016
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into either interventional (acenocoumarol) or placebo group along with first five days of subcutaneous Low Molecular Weight Heparin inj. Enoxaparin in the interventional arm and placebo injection in the control arm. Every 3 monthly the Doppler screening for recanalization of portal vein thrombus will be done with monitoring of International Normalized Ratio (INR)with target INR 2-3. Both the groups will receive the therapy for one year irrespective of the Doppler findings in relation to portal vein thrombus re-canalization.Then one year drug free monitoring will be done in both the groups as per the primary or secondary outcome. .

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• A clinical, radiological or histologic diagnosis of cirrhosis

• Partial or total Portal vein thrombus (evidence of chronic thrombus)

• Informed consent to participate in the study

Exclusion Criteria:

• Acute thrombus in Portal vein

• Hepatocellular carcinoma or any other malignancy,

• Hypercoagulable state other than the liver disease related

• DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.

• Base line INR >2

• Child Turcott Pugh score>11

• Recent peptic ulcer disease

• History of Hemorrhagic stroke

• Pregnancy.

• Uncontrolled Hypertension

• Age>70 yrs

• Non responders to beta-blocker requiring Endoscopic Variceal Ligation

Related Conditions & MeSH terms

• Portal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Enoxaparin with acenocoumarol
enoxaparin 100mcg/kg for 5days along with acenocoumarol 2mg to start with and dose to be adjusted for the target INR

Other:
• placebo
injection placebo will be given for 5 days along with placebo tablets

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences.	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportions of patients who will achieve Recanalization of thrombus (complete i.e No thrombus is seen or partial i.e up to 50% of the lumen become patent.)on oral anticoagulant acenocoumarol during the study period of 2 year from randomization.		2 years
Secondary	Proportions of patients who will show improvement in Child Turcott Pugh (CTP) (>2 points)in both groups		2 years
Secondary	Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups		2 years
Secondary	Proportions of patients who will achieve reduction in liver stiffness > 5 Kpa by transient elastography in both groups		2 years
Secondary	Proportions of patients will show decrease in hepatic decompensation i.e hepatic encephalopathy,ascites,hepato renal syndrome,variceal bleed,jaundice and coagulopathy in both groups.		2 years