Carvedilol vs Band Ligation vs Combination Therapy for Primary Prophylaxis of Variceal Bleeding

NCT02066649 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: Pro2013003729
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects will be those individuals greater than 18 years of age with a diagnosis of cirrhosis undergoing screening for esophageal varices. Eligible subjects will have a diagnosis of cirrhosis and esophageal varices (graded as medium or large) with no prior history of variceal bleeding. The diagnosis of cirrhosis will be based on clinical, radiologic, and/or laboratory data. Patients will be randomly assigned using electronic medical records to one of three treatment arms after screening esophagogastroduodenoscopy (EGD) has been performed and large varices are identified. Primary outcome of the study will be the incidence of variceal bleeding in patients receiving one of the following therapies for primary prophylaxis of variceal bleeding: carvedilol, variceal band ligation (VBL), or both carvedilol and VBL.

Conditions

Portal Hypertension Related to Cirrhosis

Keywords

portal hypertension; esophageal varices; variceal bleed; carvedilol; variceal band ligation

Outcome Measures

Primary Outcomes (1)

• Incidence of first variceal bleed

  within 2 year follow-up period

Secondary Outcomes (3)

• Bleed-related mortality

  within 2-year follow-up period

• Overall mortality

  Within 2 year follow-up period

• Recurrence of varices

  within 2 year follow-up period

Study Arms (3)

Carvedilol

ACTIVE COMPARATOR

Initiating patient on carvedilol after diagnosis of varices made on endoscopy

Drug: Carvedilol

Variceal Band Ligation

ACTIVE COMPARATOR

performing variceal band ligation during endoscopy on patient after diagnosis of esophageal varices made on endoscopy

Procedure: Variceal band ligation

Combination Group (Carvedilol + Variceal band ligation)

ACTIVE COMPARATOR

once patient has confirmed large esophageal varices on endoscopy, he/she will be started on carvedilol (post-procedure) in addition to having variceal band ligation performed during endoscopy

Drug: Carvedilol; Procedure: Variceal band ligation

Interventions

Carvedilol DRUG

Administering carvedilol to patients diagnosed with large varices on endoscopy

Also known as: Coreg

Carvedilol; Combination Group (Carvedilol + Variceal band ligation)

Variceal band ligation PROCEDURE

Performing variceal band ligation during endoscopy after diagnosis of large varices on endoscopy

Combination Group (Carvedilol + Variceal band ligation); Variceal Band Ligation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers NJ Medical School

Newark, New Jersey, 07103, United States

Location

Related Publications (1)

• Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available.

  PMID: 17879356 BACKGROUND

MeSH Terms

Conditions

Hypertension, Portal; Esophageal and Gastric Varices

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• NIKOLAOS T PYRSOPOULOS, MD

  RUTGERS - NJMS- DEPARTMENT OF MEDICINE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Chief of Gastroenterology & Hepatology

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 19, 2014
• Study Start: July 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: September 1, 2021
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

US (1)