Trial | NCT01103154  Report issue

Title

A Trial of Nadolol Plus Isosorbide Mononitrate Versus Carvedilol for the Prevention of Variceal Rebleeding
A Controlled Trial of Nadolol Plus Isosorbide Mononitrate vs. Carvedilol for the Prevention of Variceal Rebleeding

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    121
Carvedilol is shown to be superior to propranolol to reduce the portal pressure. This study was undertaken to compare the effectiveness and complication rates of nadolol and isosorbide mononitrate (ISMN) with carvedilol in the prevention of rebleeding from esophageal varices.
Bleeding from esophageal varices is a severe complication of portal hypertension. After initial control of acute variceal bleeding, patients have up to a 70% risk of rebleeding. Of those do rebleed, there is a 20%-35% mortality rate. Therefore, preventive procedures are required for patients surviving an episode of acute variceal bleeding. Both endoscopic injection sclerotherapy (EIS) and propranolol have been well documented to be effective for the prevention of variceal rebleeding. In recent years, endoscopic variceal ligation (EVL) has replaced EIS as the endoscopic treatment of choice in the management of bleeding esophageal varices. On the other hand, the addition of isosorbide-5-mononitrate (ISMN) has been shown to be even more effective than propranolol alone in the reduction of portal pressure and in the prevention of variceal rebleeding. A controlled trial showed that the combination of nadolol and ISMN was better than EIS in terms of prevention of variceal rebleeding and complications. The combination of nadolol and ISMN has been shown to be better than EVL in preventing variceal rebleeding. However, our study showed a contradictory result. On the other hand, carvedilol is shown to be superior to propranolol to reduce the portal pressure. This study was undertaken to compare the effectiveness and complication rates of nadolol and ISMN with carvedilol in the prevention of rebleeding from esophageal varices.
Study Started
Mar 31
2005
Primary Completion
Jan 31
2010
Study Completion
Jan 31
2010
Last Update
Oct 26
2010
Estimate

Drug nadolol + ISMN

nadolol 40-80mg ISMN 10-20mg

Drug carvedilol

6.25mg per day, increase to 6.25mg bid

Carvedilol Active Comparator

carvedilol 6.25mg per day

N+I Active Comparator

nadolol 40mg per day, ISMN 10 mg per day

Criteria 

Inclusion Criteria:

acute or recent bleeding from esophageal varices (defined below),
the etiology of portal hypertension was cirrhosis, and
age was between 20 and 70 years old.

Exclusion Criteria:

association with hepatocellular carcinoma or other malignancy,
association with cerebral vascular accident, uremia, sepsis or other debilitating disease,
had history of gastric variceal bleeding,
received beta-blocker within 1 month prior to entry,
history of contraindication to the use of beta-blockers, such as asthma, heart failure, atrioventricular block, bradycardia (pulse rate <55/min) or arterial hypotension (systolic blood pressure < 90 mmHg),
history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt),
deep jaundice (serum bilirubin > 10 mg/dl),
encephalopathy greater than stage II,
failure in control of index variceal bleeding, or
refused to participate in the trial.
No Results Posted