Carvedilol vs. Propranolol for Preventing Rebleeding After Endoscopic Treatment of Cirrhotic Varices
Sponsored by Xijing Hospital
About this trial
Last updated 4 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Started 4 months ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
* Diagnosed with cirrhosis (based on previous liver biopsy or typical clinical features) with a history of variceal bleeding, and the most recent bleeding occurred 6-30 days before enrollment
* Aged 18-75 years (based on ID card age on the enrollment date)
* Voluntarily signs the informed consent form and can cooperate with full-course follow-up and related examinations
Exclusion Criteria
* Non-cirrhotic portal hypertension (eg:Budd-Chiari syndrome, extrahepatic portal vein obstruction, idiopathic portal hypertension)
* Contraindications to non-selective beta-blockers (NSBBs) (eg:asthma, insulin-dependent diabetes mellitus, peripheral vascular disease)
* Malignant tumors (including hepatocellular carcinoma) or other life-shortening diseases (expected survival<1 year), including severe cardio-cerebrovascular diseases (eg:severe heart failure, bedridden status after cerebral infarction, cerebral hemorrhage), end-stage renal disease (requiring dialysis), severe pulmonary diseases (eg:acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis)etc
* Previous shunt or devascularization surgery, oral NSBBs, and/or endoscopic treatment for preventing recurrent variceal bleeding
* Pregnant or lactating women (female subjects must undergo a pregnancy test before enrollment; positive cases are excluded; lactating women can only enroll after stopping breastfeeding)
* Allergies to carvedilol, propranolol, or endoscopic treatment-related drugs (eg:local anesthetics, tissue adhesives)
* Severe hepatic and renal insufficiency: Child-Pugh class C with a score > 12, or MELD score > 30; serum creatinine > 221 μmol/L (2.5 mg/dl) with estimated glomerular filtration rate (eGFR) < 30 ml/(min·1.73m²)
* Severe coagulation disorders: prothrombin time (PT) prolonged by > 10 seconds, or international normalized ratio (INR) > 2.5 without effective correction measures
