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CTRI Number  CTRI/2025/01/079210 [Registered on: 22/01/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to check the effect of Apixaban on blood clots in liver cirrhosis 
Scientific Title of Study   Impact of Apixaban on portal venous thrombosis in cirrhosis: A randomised controlled trial 
Trial Acronym  ApiPort 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalimar 
Designation  Professor, Department of Gastroenterology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No.127, Ist floor, Human Nutrition Unit, Old OT block All India Institute of Medical Science, Ansari Nagar South Delhi, India-110029

South
DELHI
110029
India 
Phone  9868397211  
Fax    
Email  drshalimar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shalimar 
Designation  Professor, Department of Gastroenterology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No.127, Ist floor, Human Nutrition Unit, Old OT block All India Institute of Medical Science, Ansari Nagar South Delhi, India-110029


DELHI
110029
India 
Phone  9868397211  
Fax    
Email  drshalimar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shalimar 
Designation  Professor, Department of Gastroenterology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No.127, Ist floor, Human Nutrition Unit, Old OT block All India Institute of Medical Science, Ansari Nagar South Delhi, India-110029


DELHI
110029
India 
Phone  9868397211  
Fax    
Email  drshalimar@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Sri Aurobindo Marg, Ansari Nagar East, New Delhi, Delhi, India-110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences  
Address  Department of Gastroenterology and Human Nutrition Unit, Room no 3111, 3rd floor teaching block All India Institute of Medical Sciences, New Delhi Sri Aurobindo Marg, Ansari Nagar East, New Delhi, Delhi, India- 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shalimar  All India Institute of Medical Sciences   Room No. 127,First floor, Old OT block,Department of Gastroenterology and Human Nutrition Unit, AIIMS South Delhi, India-110029
South
DELHI 		 9868397211

drshalimar@gmail.com 
Dr Arun Valsan  Amrita Institute of Medical Sciences  Room no 1002, Division of Gastroenterology and Hepatology
Ernakulam
KERALA 		 8411051156

drarunvalsan@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee of Amrita School of Medicine  Approved 
Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi   Approved 
Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Apixaban plus standard of care  Tablet Apixaban 5 mg twice daily orally plus standard of care (routine medications according to existing guidelines) for 1 year. 
Comparator Agent  Standard of care  Standard of care includes routine medications that will be given to the cirrhotic patients according to existing guidelines for 1 year. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  A. Adults more than or equal to 18 years
B. Patients diagnosed with cirrhosis based on clinical and/or laboratory criteria, ultrasound/fibroscan/liver biopsy.
C. Thrombosis in portal venous system
D. Written informed consent
 
 
ExclusionCriteria 
Details  1. Hepatic venous outflow tract obstruction
2. Triple positive antiphospholipid antibody syndrome
3. Hepatocellular or malignant neoplasia at the time of inclusion
4. Active bleeding from any site (e.g., active variceal bleeding)
5. High risk varices at the time of inclusion
6. Hypersensitivity to active ingredients or excipients
7. Pregnancy and lactation
8. Any comorbidity involving therapeutic limitation and/or life expectancy less than 12 months
9. Renal impairment (creatinine clearance less than 15 ml/min or on hemodialysis)
10. HE grades 2 or higher
11. Severe thrombocytopenia less than 20k/mm3
12. TIPSS
13. Potent dual inhibitors of CYP3A4 and P-gp, (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin) or dual inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort)
14. Coadministration of antiplatelet drugs 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients with partial or complete recanalization of portal venous thrombosis  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of adverse events-major and minor bleed  12 months 
Proportion of patients with progression of portal venous thrombosis   12 months 
Predictors of recanalization of thrombosis

 		 12 months 
Frequency of individual and composite of liver-related events (ascites, hepatic encephalopathy, variceal bleeding, ACLF and HCC)  12 months 
Change in CTP, MELD and non-invasive liver fibrosis score  12 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   03/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Studies have observed that traditional anticoagulants (warfarin and low molecular weight heparin) are safe and effective in the treatment of portal vein thrombosis in cirrhotic patients. Recent studies in patients suffering from cardiac diseases have shown better efficacy and lesser side effects of newer direct oral anticoagulants like apixaban compared to traditional anticoagulants in cirrhosis. But there is dearth of studies evaluating the efficacy and safety of the newer anticoagulants in recanalization of portal venous thrombosis in patients with cirrhosis. Therefore, we plan to conduct this study to assess the impact of apixaban in recanalisation of portal venous thrombosis and other clinically significant outcomes like hepatic decompensation in cirrhotic patients. 
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