Contact information
Type
Scientific
Primary contact
Prof Peter Hayes
ORCID ID
Contact details
Department of Hepatology
University of Edinburgh
Little France
Edinburgh
EH16 4SA
United Kingdom
+44 (0)131 242 1625
p.hayes@ed.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LREC/1999/4/197
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Ethical approval obtained from Lothian Research Ethics Committee on 14th February 2000.
Study design
Prospective multicentre randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cirrhosis and portal hypertension
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Carvedilol
Primary outcome measure
The first variceal bleed.
The outcomes were measured for the entire follow up period and also at 6, 12, and 24 months.
Secondary outcome measures
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.
Overall trial start date
14/02/2000
Overall trial end date
24/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Liver cirrhosis and the presence of Grade II or larger oesophageal varices.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
152
Participant exclusion criteria
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
Recruitment start date
14/02/2000
Recruitment end date
24/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Hepatology
Edinburgh
EH16 4SA
United Kingdom
Sponsor information
Organisation
University of Edinburgh (UK)
Sponsor details
Royal Infirmary
Little France
Edinburgh
EH16 4SB
United Kingdom
mvm@ed.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Edinburgh (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19610055
Publication citations
-
Results
Tripathi D, Ferguson JW, Kochar N, Leithead JA, Therapondos G, McAvoy NC, Stanley AJ, Forrest EH, Hislop WS, Mills PR, Hayes PC, Randomized controlled trial of carvedilol versus variceal band ligation for the prevention of the first variceal bleed., Hepatology, 2009, 50, 3, 825-833, doi: 10.1002/hep.23045.