A study on impact of addition of simvastatin to carvedilol on survival in patients with decompensated cirrhosis after an episode of acute variceal bleeding

Not Applicable

Completed

• Conditions: Health Condition 1: K74- Fibrosis and cirrhosis of liver

• Registration Number: CTRI/2022/07/044263
• Lead Sponsor: PROF ANOOP SARAYA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-05-01
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 268

Inclusion Criteria

Patients with cirrhosis (upto CTP score up to 12) after an episode of variceal bleeding being started on carvedilol for secondary prophylaxis will be screened for inclusion.

Exclusion Criteria

Subjects who meet any of the following exclusion criteria will not be randomised in this study.

1)Cirrhosis with CTP score >12

2)Grade III ascites at presentation

3)Acute on chronic liver failure at presentation

4)Cirrhosis with HCC

5)Isolated Bleeding from gastric varices

6)Pregnancy or lactation

7)Contraindications to statins or beta blockers

9)Acute kidney injury (serum creatinine >1.5mg/dl)

10)Unwilling to participate

11)Patients undergoing rescue therapy like Ella-Dennis stent placement or rTIPS.

12)Non-cirrhotic portal hypertension

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative rate of transplant free survival in both arms at end of 24 months of follow-up assessed using per-protocol and intention to treat analysis.Timepoint: Cumulative rate of transplant free survival in both arms at end of 24 months of follow-up assessed using per-protocol and intention to treat analysis.

Secondary Outcome Measures

Name	Time	Method
Cumulative rates of events assessed using competing risk analysis at the end of follow-up period <br/ ><br>1)Variceal rebleeding <br/ ><br>2)New onset/worsening ascites <br/ ><br>3)Complications like HE, AKI <br/ ><br>4)Infections <br/ ><br>5)ACLF <br/ ><br>6)Undergoing TIPS <br/ ><br>7)All cause mortality- liver and non-liver related <br/ ><br>8)Acute coronary syndrome <br/ ><br>Timepoint: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks, and 24 months;Safety outcomes <br/ ><br>1. Statin-related hepatotoxicity <br/ ><br>2. Myositis <br/ ><br>3. RhabdomyolysisTimepoint: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks, and 24 months