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

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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: June 15, 2012
• First Posted Date: June 29, 2012
• Last Update Posted Date: June 6, 2018
• Study Start Date: June 2012
• Actual Primary Completion Date: June 1, 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 28, 2012): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 28, 2012)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Acenocoumarol for Treatment of Nontumor Portal Vein Thrombosis in Cirrhosis of Liver
• Official Title: Not Provided
• 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. .
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Portal Vein 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

Study Arms

• 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.
  Intervention: Drug: Enoxaparin with acenocoumarol
• Placebo Comparator: Placebo
  Injection placebo will be given for 5 days along with placebo tablets.
  Intervention: Other: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: June 2, 2018): 0
• Original Estimated Enrollment (submitted: June 28, 2012): 44
• Actual Study Completion Date: June 1, 2017
• Actual Primary Completion Date: June 1, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT01631877
• Other Study ID Numbers: ILBS- PVT-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Institute of Liver and Biliary Sciences, India
• Study Sponsor: Institute of Liver and Biliary Sciences, India
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Institute of Liver and Biliary Sciences, India
• Verification Date: December 2016