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

NCT ID: NCT02385422

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Carvedilol

Carvedilol，6.25mg-25mg/d,oral,6 months

Group Type: EXPERIMENTAL

Carvedilol

Intervention Type: DRUG

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.

Propranolol

Propranolol,30mg-160mg/d,oral,6 months

Group Type: ACTIVE_COMPARATOR

Propranolol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

JinLuo; XinDeAn

Eligibility Criteria

Inclusion Criteria

• age between 18-70 years old;
• cirrhotic patients referred to Zhongshan Hospital with esophagogastric varices confirmed by endoscopy;
• history of variceal bleeding; at least 3 times of endoscopic treatment;
• with 1) mild esophageal varices;2) gastric varices with a diameter less than 5mm; or 3) variceal eradication at the time of recruiting.

Exclusion Criteria

Patients are excluded when they have

• episodes of variceal bleeding after the last endoscopic treatment;
• diagnosis of hepatic cellular carcinoma;
• severe systemic diseases;
• refractory ascites;
• contraindication to Carvedilol or Propranolol, such as: asthma, chronic obstructive pulmonary disease, allergic rhinitis, New York Heart Association IV chronic heart failure, atrioventricular blockade, severe bradycardia(HR<50bpm), sick sinus syndrome, cardiogenic shock, severe hypotension(ABPsys<85mmHg);
• previous and continued use of β-blockers;
• Child -Pugh Class C.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shiyao Chen

Director of department of Gastroenterology, Zhongshan Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shiyao Chen, Professor

Role: STUDY_DIRECTOR

Shanghai Zhongshan Hospital

Locations

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shiyao Chen, Professor

Role: CONTACT

chen.shiyao@zs-hospital.sh.cn

86-13601767310

Facility Contacts

Yichao Wei, Doctor

Role: primary

08301010253@fudan.edu.cn

86-13918891342

Other Identifiers

CSY-WYC-2015

Identifier Type: -

Identifier Source: org_study_id