NCT01383044

Brief Summary

Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in prophylaxis of the first bleeding. The efficacy \& safety of combining EVL and carvedilol in prophylaxis of the first bleeding is still unknown. This study aims to investigate the value of combination therapy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

July 8, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2015

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

4.1 years

First QC Date

June 16, 2011

Last Update Submit

November 19, 2020

Conditions

Variceal Bleeding

Keywords

CarvedilolBanding ligation with Carvedilolthe efficacy & safety of combining EVL and carvedilol in prevention of first variceal bleeding

Outcome Measures

Primary Outcomes (1)

  • patients with first bleeding

    the difference of bleeding episode in both groups.

    3 years

Secondary Outcomes (1)

  • patients with complications and mortality rates

    3 years

Study Arms (2)

EVL + carvedilol

EXPERIMENTAL

EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day

Procedure: EVL + carvedilol

carvedilol

ACTIVE COMPARATOR

carvedilol 6.25-12.5 mg per day

Drug: carvedilol

Interventions

EVL + carvedilolPROCEDURE

EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day

EVL + carvedilol
carvedilolDRUG

carvedilol 6.25mg-12.5 mg per day

carvedilol

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhosis with esophageal varices are larger than F2.
  • No history of variceal bleeding.
  • In three months have not implemented preventive esophageal variceal ligation. (4)age 20yrs～75yrs.

You may not qualify if:

  • Association with HCC or other cancers .
  • Refractory ascites.
  • Jaundice, bilirubin \> 5mg/dl.
  • Encephalopathy.
  • Cr.\>3mg/dL.
  • A-V,block bradycardia (PR \< 60/mim).
  • Hypotension systolic blood pressure\<95/mmHg .
  • Refusal to participate.
  • Carvedilol allergy
  • Second degree-third degree Atrio-ventricular block.
  • Bradycardia.
  • WPWsyndrome
  • Hypotension
  • Psychogenic shock.
  • Asthma. All the patients are randomized based on a random number.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E-DA hospital

Kaogsiung, 82445, Taiwan

Location

MeSH Terms

Interventions

Carvedilol

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 28, 2011

Study Start

July 8, 2011

Primary Completion

July 30, 2015

Study Completion

June 30, 2020

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations

TW(1)