NCT02385422

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

March 4, 2015

Last Update Submit

March 9, 2015

Conditions

Liver CirrhosisEsophageal and Gastric VaricesHemorrhage

Keywords

secondary prophylaxisPropranololCarvedilolcomparative effectiveness research

Outcome Measures

Primary Outcomes (1)

  • Endoscopic Retreatment

    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.

    6 months

Secondary Outcomes (3)

  • Rebleeding rate

    6 months

  • Mortality rate

    6 months

  • Adverse events

    6 months

Study Arms (2)

Carvedilol

EXPERIMENTAL

Carvedilol，6.25mg-25mg/d,oral,6 months

Drug: Carvedilol

Propranolol

ACTIVE COMPARATOR

Propranolol,30mg-160mg/d,oral,6 months

Drug: Propranolol

Interventions

CarvedilolDRUG

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.

Also known as: JinLuo
Carvedilol
PropranololDRUG

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.

Also known as: XinDeAn
Propranolol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisEsophageal and Gastric VaricesHemorrhage

Interventions

CarvedilolPropranolol

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesHypertension, Portal

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingPhenoxypropanolaminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Shiyao Chen, Professor

    Shanghai Zhongshan Hospital

    STUDY DIRECTOR

Central Study Contacts

Shiyao Chen, Professor

CONTACT

86-13601767310chen.shiyao@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department of Gastroenterology, Zhongshan Hospital

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 11, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2017

Study Completion

November 1, 2017

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

CN(1)