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ISRCTN
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ISRCTN26269039
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of carvedilol versus variceal band ligation in the primary prophylaxis of oesophageal variceal haemorrhage
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Scientific title
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Acronym
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N/A
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Serial number at source
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LREC/1999/4/197
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Study hypothesis
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Carvedilol, a vasodilating non-selective beta blocker is more effective than variceal band ligation in the prevention of the first variceal bleed in patients with high risk varices.
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Ethics approval
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Ethical approval obtained from Lothian Research Ethics Committee on 14th February 2000.
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Study design
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Prospective multicentre randomised controlled clinical trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cirrhosis and portal hypertension
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Participants - inclusion criteria
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Liver cirrhosis and the presence of Grade II or larger oesophageal varices.
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Participants - exclusion criteria
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1. Aged less than 18 or greater than 75
2. Medication: vasoactive drugs such as beta blockers or nitrates
3. Advanced cardiopulmonary disease
4. Malignancy with prognosis that will affect study outcome
5. Allergy to carvedilol
6. Patients with obstructive airways disease
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Anticipated start date
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14/02/2000
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Anticipated end date
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24/05/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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152
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Interventions
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1. Carvedilol starting at 6.25 mg per day for a week, to increase to 12.5 per day thereafter if tolerated
2. Variceal band ligation to be performed every two weeks until variceal eradication
The follow up periods for the carvedilol and banding arms are 23.3 ± 21.1 months and 22.1 ± 22.3 months respectively.
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Primary outcome measure(s)
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The first variceal bleed.
The outcomes were measured for the entire follow up period and also at 6, 12, and 24 months.
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Secondary outcome measure(s)
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1. Overall mortality
2. Variceal bleeding related mortality
3. Adverse events leading to treatment discontinuation
The outcomes were measured for the entire follow up period and also at 6, 12, and 24 months. Bleeding induced mortality was defined as death within 6 weeks of the index variceal bleed.
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Sources of funding
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University of Edinburgh (UK)
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Trial website
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Publications
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Contact name
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Prof
Peter
Hayes
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Address
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Department of Hepatology
University of Edinburgh
Little France
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City/town
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Edinburgh
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Zip/Postcode
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EH16 4SA
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Country
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United Kingdom
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Tel
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+44 (0)131 242 1625
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Email
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p.hayes@ed.ac.uk
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Sponsor
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University of Edinburgh (UK)
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Address
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Royal Infirmary
Little France
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City/town
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Edinburgh
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Zip/Postcode
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EH16 4SB
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Country
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United Kingdom
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Email
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mvm@ed.ac.uk
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Sponsor website:
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http://www.ed.ac.uk/
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Date applied
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09/06/2007
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Last edited
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05/07/2007
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Date ISRCTN assigned
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05/07/2007
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