The Effect of Carvedilol Vs Propranolol in Cirrhotic Patients With Variceal Bleeding
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|ClinicalTrials.gov Identifier: NCT02385422|
Recruitment Status : Unknown
Verified March 2015 by Shiyao Chen, Shanghai Zhongshan Hospital.
Recruitment status was: Recruiting
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis Esophageal and Gastric Varices Hemorrhage||Drug: Carvedilol Drug: Propranolol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Carvedilol Vs Propranolol in Patients With Cirrhosis Related Esophagogastric Varices After Multiple Endoscopic Treatments For Secondary Prophylaxis:A Randomized Controlled Trial|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||November 2017|
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.
Other Name: JinLuo
Active Comparator: 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.
Other Name: XinDeAn
- Endoscopic Retreatment [ Time Frame: 6 months ]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.
- Rebleeding rate [ Time Frame: 6 months ]We observe the variceal rebleeding events during 6 months.
- Mortality rate [ Time Frame: 6 months ]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.
- Adverse events [ Time Frame: 6 months ]We observe any severe adverse events caused by drug treatment,including palpitation,bronchospasm,syncope,dizziness,hypotension,ascites,edema,bradycardia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385422
|Contact: Shiyao Chen, Professorfirstname.lastname@example.org|
|Shanghai Zhongshan Hospital||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Yichao Wei, Doctor 86-13918891342 email@example.com|
|Principal Investigator: Shiyao Chen, Professor|
|Study Director:||Shiyao Chen, Professor||Shanghai Zhongshan Hospital|