NCT02385422

The Effect of Carvedilol Vs Propranolol in Cirrhotic Patients With Variceal Bleeding

The Effect of Carvedilol Vs Propranolol in Patients With Cirrhosis Related Esophagogastric Varices After Multiple Endoscopic Treatments For Secondary Prophylaxis:A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety of Carvedilol and Propranolol in patients with cirrhosis-related esophagogastric varices after multiple endoscopic treatments for secondary prophylaxis.

Detailed description

The study is a randomized controlled trial. Patients randomly enter into two treatment groups: 1)the Carvedilol group and 2)the Propranolol group. Treatment allocation is by block randomization, with an equal number for Carvedilol and Propranolol. The results are concealed in opaque envelopes. The dose of non-selective β-blocker(NSBB) is titrated according to systolic arterial blood pressure (ABPsys) and heart rate (HR). Doses are increased every 2-3 days until ABPsys is not less than 90 mm Hg and HR is not less than 55 bpm. Carvedilol is started at a dose of 6.25mg/d, and titrated to a maximum dose of 25mg/d. Patients receiving propranolol start at a dose of 30 mg/day and the dose will be increased to a maximum dose of 160 mg/day. Patients will be followed up with telephone calls every 2 months. After taking these 2 drugs for 6 months, patients come for clinic visits, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.

Conditions

• Liver Cirrhosis
• Esophageal and Gastric Varices
• Hemorrhage

Interventions

Type	Name	Description
DRUG	Carvedilol	Carvedilol is started at a dose of 6.25mg/d, and titrated to a maximum dose of 25mg/d. Doses are increased every 2-3 days until ABPsys is not less than 90 mm Hg and HR is not less than 55 bpm.
DRUG	Propranolol	Patients receiving propranolol start at a dose of 30 mg/d and the dose will be increased to a maximum dose of 160 mg/d.Doses are increased every 2-3 days until ABPsys is not less than 90 mm Hg and HR is not less than 55 bpm.

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-06-01
• Completion: 2017-11-01
• First posted: 2015-03-11
• Last updated: 2015-03-11

Locations

1 site across 1 country: China