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

NCT ID: NCT01103154

Last Updated: 2010-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Variceal Rebleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Carvedilol

carvedilol 6.25mg per day

Group Type ACTIVE_COMPARATOR

carvedilol

Intervention Type DRUG

6.25mg per day, increase to 6.25mg bid

N+I

nadolol 40mg per day, ISMN 10 mg per day

Group Type ACTIVE_COMPARATOR

nadolol + ISMN

Intervention Type DRUG

nadolol 40-80mg ISMN 10-20mg

Interventions

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carvedilol

6.25mg per day, increase to 6.25mg bid

Intervention Type DRUG

nadolol + ISMN

nadolol 40-80mg ISMN 10-20mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. association with hepatocellular carcinoma or other malignancy,
2. association with cerebral vascular accident, uremia, sepsis or other debilitating disease,
3. had history of gastric variceal bleeding,
4. received beta-blocker within 1 month prior to entry,
5. 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),
6. history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt),
7. deep jaundice (serum bilirubin \> 10 mg/dl),
8. encephalopathy greater than stage II,
9. failure in control of index variceal bleeding, or
10. refused to participate in the trial.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

E-DA Hospital

OTHER

Sponsor Role lead

Responsible Party

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E-DA Hospital

Related Links

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http://erad.nhri.org.tw/start

National Health Research Institute, Taiwan

Other Identifiers

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vghks96CT2-13

Identifier Type: OTHER

Identifier Source: secondary_id

Carvedilol vs. N+I

Identifier Type: -

Identifier Source: org_study_id