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

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ClinicalTrials.gov Identifier: NCT01631877
Recruitment Status : Withdrawn (lack of funds)
First Posted : June 29, 2012
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Study Description
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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. .

Condition or disease Intervention/treatment Phase
Portal Vein Thrombosis Drug: Enoxaparin with acenocoumarol Other: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2012
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Proportions of patients who will show improvement in Child Turcott Pugh (CTP) (>2 points)in both groups [ Time Frame: 2 years ]
  2. Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups [ Time Frame: 2 years ]
  3. Proportions of patients who will achieve reduction in liver stiffness > 5 Kpa by transient elastography in both groups [ Time Frame: 2 years ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631877


Locations
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India
Institute of Liver and Biliary Sciences.
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
More Information
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01631877    
Other Study ID Numbers: ILBS- PVT-01
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: December 2016
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
 Acenocoumarol
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action