drugset / Trial / NCT00766805

Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis

NCT00766805

Completed 177 enrolled Govind Ballabh Pant Hospital
RandomizedSingle-groupOpen-labelPrevention

Summary

Background: Both endoscopic variceal ligation (EVL) and propranolol are valuable methods for secondary prophylaxis of variceal bleeding. Addition of ISMN to propranolol improves the efficacy of drug therapy. It is hypothesized that a combination of EVL and portal pressure reducing drugs should significantly be better than EVL alone. Patients and Methods: Patients with history of variceal bleed were randomized to EVL plus drugs (propranolol and ISMN) or EVL alone. EVL was repeated every 3-4 weeks until variceal eradication. Propranolol dose was adjusted to reduce the resting heart rate to 55 bpm. Dose of ISMN was 40 mg/d. Primary end points were rebleed or death. Secondary end points included complications of portal hypertension and the development of serious adverse effects to therapy.

Timeline

Start
2002-10
Primary completion
2006-12
Completion
2007-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Isosorbide Mononitrate Other / unclassified 40 mg
Comparator Propranolol Small molecule

Indications