- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01103154
A Trial of Nadolol Plus Isosorbide Mononitrate Versus Carvedilol for the Prevention of Variceal Rebleeding (Carvedilol)
October 24, 2010 updated by: E-DA Hospital
A Controlled Trial of Nadolol Plus Isosorbide Mononitrate vs. Carvedilol for the Prevention of Variceal Rebleeding
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 Type
Interventional
Enrollment (Actual)
121
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Carvedilol
carvedilol 6.25mg per day
|
6.25mg per day, increase to 6.25mg bid
|
Active Comparator: N+I
nadolol 40mg per day, ISMN 10 mg per day
|
nadolol 40-80mg ISMN 10-20mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
variceal rebleeding
Time Frame: 2 years
|
hematemesis or melena,requiring blood transfusion of 2 units or more bleeding source was proven endoscopically to be from esophageal varices
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse events, mortality
Time Frame: 2 years
|
hypotension, bradycardia, dizziness, impotence, shortness of breath survival
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
January 1, 2010
Study Completion
January 1, 2010
Study Registration Dates
First Submitted
April 9, 2010
First Submitted That Met QC Criteria
April 12, 2010
First Posted (Estimate)
April 14, 2010
Study Record Updates
Last Update Posted (Estimate)
October 26, 2010
Last Update Submitted That Met QC Criteria
October 24, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Antioxidants
- Sympatholytics
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Carvedilol
- Nadolol
Other Study ID Numbers
- Carvedilol vs. N+I
- vghks96CT2-13 (Other Identifier: vghks96CT2-13)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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