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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01631877
First received: June 15, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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. .


Condition Intervention
Portal Vein Thrombosis
Drug: Enoxaparin with acenocoumarol
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportions of patients who will show improvement in Child Turcott Pugh (CTP) (>2 points)in both groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Proportions of patients who will achieve reduction in liver stiffness > 5 Kpa by transient elastography in both groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: enoxaparin with acenocoumarol
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
enoxaparin 100mcg/kg for 5days along with acenocoumarol 2mg to start with and dose to be adjusted for the target INR
Placebo Comparator: Placebo
Injection placebo will be given for 5 days along with placebo tablets.
Other: placebo
injection placebo will be given for 5 days along with placebo tablets

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631877

Contacts
Contact: Ashok Kr Choudhory, MD 9953186205

Locations
India
Institute of Liver and Biliary Sciences. Recruiting
New Delhi, Delhi, India, 110070
Contact: Ankit Bhardwaj    9717270640    bhardwaj.ankit3@gmail.com   
Principal Investigator: Ashok Kr Choudhury, MD         
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01631877     History of Changes
Other Study ID Numbers: ILBS- PVT-001
Study First Received: June 15, 2012
Last Updated: December 16, 2013
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Acenocoumarol
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 21, 2014