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

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Hemorrhage; Liver Cirrhosis; Esophageal and Gastric Varices

Treatments: Drug: Carvedilol; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT02385422

CSY-WYC-2015

Details and patient eligibility

About

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

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

480 participants in 2 patient groups

Carvedilol

Experimental group

Description:

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

Treatment:

Drug: Carvedilol

Propranolol

Active Comparator group

Description:

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

Treatment:

Drug: Propranolol