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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02385422
Other study ID # CSY-WYC-2015
Secondary ID
Status Recruiting
Phase Phase 4
First received March 4, 2015
Last updated March 9, 2015
Start date March 2015
Est. completion date November 2017

Study information

Verified date March 2015
Source Shanghai Zhongshan Hospital
Contact Shiyao Chen, Professor
Phone 86-13601767310
Email chen.shiyao@zs-hospital.sh.cn
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 480
Est. completion date November 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 ß-blockers;

- Child -Pugh Class C.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

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.
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.

Locations

Country Name City State
China Shanghai Zhongshan Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endoscopic Retreatment Patients will receive an endoscopic examination after they have been followed up for 6 months, and if they have recurrence of varices or deterioration of varices,they are considered to be in need of endoscopic retreatment. 6 months No
Secondary Rebleeding rate We observe the variceal rebleeding events during 6 months. 6 months No
Secondary Mortality rate We observe the mortality events during 6 months due to variceal bleeding, hepatic encephalopathy, liver failure, hepatic cellular carcinoma, hepatic-renal syndrome and spontaneous bacterial peritonitis. 6 months No
Secondary Adverse events We observe any severe adverse events caused by drug treatment,including palpitation,bronchospasm,syncope,dizziness,hypotension,ascites,edema,bradycardia. 6 months Yes
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