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Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding Comparing Carvedilol and Endoscopic Therapy: A Multicenter Randomized Controlled Trial
To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.
The study is a randomized controlled trial. Patients randomly enter into two treatment groups: 1)the Carvedilol group and 2)the endoscopy group. Treatment allocation is by block randomization, with an two-to-one ratio for Carvedilol and endoscopy. The results are concealed in opaque envelopes. The dose of Carvedilol is titrated according to systolic arterial blood pressure (ABPsys) and heart rate (HR). Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm. Carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d. Patients receiving endoscopic therapy every 4 weeks until eradication of varices. Patients will come for clinic visit every 6 months, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Zhongshan Hospital
Shanghai, China
Start Date
December 1, 2015
Primary Completion Date
September 1, 2018
Completion Date
September 1, 2018
Last Updated
March 1, 2016
792
ESTIMATED participants
Carvedilol
DRUG
endoscopy
DEVICE
Lead Sponsor
Shanghai Zhongshan Hospital
Collaborators
NCT06169592
NCT07275554
Data Source & Attribution
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