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

NCT02066649 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-07-24

No results posted yet for this study

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

Interventions

DRUG

Carvedilol

Administering carvedilol to patients diagnosed with large varices on endoscopy

PROCEDURE

Variceal band ligation

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

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • NIKOLAOS T PYRSOPOULOS, MD · RUTGERS - NJMS- DEPARTMENT OF MEDICINE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2019-03-31
Completion
2021-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02066649 on ClinicalTrials.gov