CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 121 enrolled
Drug / intervention
carvedilol +1 moredrug
Likely dose
carvedilol 6.25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02504723
NCT02504723Phase 4Completed

Carvedilol Plus Endoscopic Cyanoacrylate Injection Versus Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding

Kaohsiung Veterans General Hospital.·interventional·Posted Jul 22, 2015·Updated Aug 21, 2017

In Brief

A Phase 4 clinical trial evaluating carvedilol and cyanoacrylate for Esophageal and Gastric Varices. Completed, enrolled 121 participants across 1 site.

Detailed Summary

Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2015
Enrollment StartDec 1, 2011
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.9 years ago

Interventions

carvediloldrug

Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure \>90 mm Hg.

cyanoacrylatedrug

The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.