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

NCT01631877 | Withdrawn

• 1 other identifier: ILBS- PVT-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. .

Conditions

Portal Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportions of patients who will show improvement in Child Turcott Pugh (CTP) (>2 points)in both groups

  2 years

• Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups

  2 years

• Proportions of patients who will achieve reduction in liver stiffness > 5 Kpa by transient elastography in both groups

  2 years

• 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

Study Arms (2)

enoxaparin with acenocoumarol

EXPERIMENTAL

Patients will receive enoxaparin 100mcg/kg for 5days along with acenocoumarol 2mg with titration of dose to maintain a target INR of 2-3.intially the INR will be monitored twice weekly with gradual escalation of dose to achieve target INR.After achieving the target INR this is to be repeated every 4th weekly. The Doppler Ultra Sonography screening will be done every 3monthly to assess the recanalization of portal vein thrombus but the medications will be continue for one year irrespective of recanalization.

Drug: Enoxaparin with acenocoumarol

Placebo

PLACEBO COMPARATOR

Injection placebo will be given for 5 days along with placebo tablets.

Other: placebo

Interventions

Enoxaparin with acenocoumarol DRUG

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

enoxaparin with acenocoumarol

placebo OTHER

injection placebo will be given for 5 days along with placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences.

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Enoxaparin; Acenocoumarol

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 29, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 6, 2018

Record last verified: 2016-12

Locations

IN (1)