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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
Sponsor:
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Esophageal and Gastric Varices Hemorrhage Drug: Carvedilol Drug: Propranolol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
Experimental: Carvedilol
Carvedilol,6.25mg-25mg/d,oral,6 months
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.
Other Name: JinLuo

Active Comparator: Propranolol
Propranolol,30mg-160mg/d,oral,6 months
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.
Other Name: XinDeAn




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rebleeding rate [ Time Frame: 6 months ]
    We observe the variceal rebleeding events during 6 months.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Shiyao Chen, Professor 86-13601767310 chen.shiyao@zs-hospital.sh.cn

Locations
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China, Shanghai
Shanghai Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Yichao Wei, Doctor    86-13918891342    08301010253@fudan.edu.cn   
Principal Investigator: Shiyao Chen, Professor         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Director: Shiyao Chen, Professor Shanghai Zhongshan Hospital

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Responsible Party: Shiyao Chen, Director of department of Gastroenterology, Zhongshan Hospital, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02385422     History of Changes
Other Study ID Numbers: CSY-WYC-2015
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015

Keywords provided by Shiyao Chen, Shanghai Zhongshan Hospital:
secondary prophylaxis
Propranolol
Carvedilol
comparative effectiveness research

Additional relevant MeSH terms:
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Hemorrhage
Fibrosis
Liver Cirrhosis
Esophageal and Gastric Varices
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal
Propranolol
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists