Health Condition 1: K74- Fibrosis and cirrhosis of liver
Conditions
Interventions
Intervention1: Impact of addition of simvastatin to carvedilol on survival in patients with decompensated cirrhosis after an episode of acute variceal bleeding: In addition to Carvedilol, Simvastatin
Sponsors
PROF ANOOP SARAYA
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Cumulative rates of events assessed using competing risk analysis at the end of follow-up period 1) Variceal rebleeding 2) New onset/worsening ascites 3) Complications like HE, AKI 4) Infections 5) ACLF 6) Undergoing TIPS 7) All cause mortality- liver and non-liver related 8) Acute coronary syndrome Timepoint: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks, and 24 months;Safety outcomes 1. Statin-related hepatotoxicity 2. Myositis 3. RhabdomyolysisTimepoint: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks, and 24 months | — |
Countries
India
Contacts
Public ContactDr. Deepak Gunjan
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Outcome results
None listed