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

NCT01103154 | Completed Phase 4 DMC

• 2 other identifiers: Carvedilol vs. N+Ivghks96CT2-13
• Study Type: interventional
• Target: 121
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Variceal Rebleeding

Keywords

beta blocker; variceal rebleeding; efficacy and safety in reducing variceal rebleeding

Outcome Measures

Primary Outcomes (1)

• variceal rebleeding

  hematemesis or melena,requiring blood transfusion of 2 units or more bleeding source was proven endoscopically to be from esophageal varices

  2 years

Secondary Outcomes (1)

• adverse events, mortality

  2 years

Study Arms (2)

Carvedilol

ACTIVE COMPARATOR

carvedilol 6.25mg per day

Drug: carvedilol

N+I

ACTIVE COMPARATOR

nadolol 40mg per day, ISMN 10 mg per day

Drug: nadolol + ISMN

Interventions

carvedilol DRUG

6.25mg per day, increase to 6.25mg bid

Carvedilol

nadolol + ISMN DRUG

nadolol 40-80mg ISMN 10-20mg

N+I

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• E-DA Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Related Links

• National Health Research Institute, Taiwan

MeSH Terms

Interventions

Carvedilol; Nadolol

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Phenoxypropanolamines

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: April 9, 2010
• First Posted: April 14, 2010
• Study Start: March 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 26, 2010

Record last verified: 2010-10