Condition category
Digestive System
Date applied
09/06/2007
Date assigned
05/07/2007
Last edited
21/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ed.ac.uk/

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19610055

Publication citations

  1. 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.

Additional files

Editorial Notes