| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN26269039 |
| Date ISRCTN assigned | 05/07/2007 |
| Local reference number(s) | LREC/1999/4/197 |
| Public title | Randomised controlled trial of carvedilol versus variceal band ligation in the primary prophylaxis of oesophageal variceal haemorrhage |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cirrhosis and portal hypertension |
| 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. |
| Design/methodology | Prospective multicentre randomised controlled clinical trial |
| Research ethics review | Ethical approval obtained from Lothian Research Ethics Committee on 14th February 2000. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Liver cirrhosis and the presence of Grade II or larger oesophageal varices. |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 14/02/2000 |
| Anticipated end date | 24/05/2006 |
| Status of trial | Completed |
| Target number of participants | 152 |
| Interventions | 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. |
| Primary outcome measure(s) | The first variceal bleed.
The outcomes were measured for the entire follow up period and also at 6, 12, and 24 months. |
| Secondary outcome measure(s) | 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. |
| Sources of funding | University of Edinburgh (UK) |
| Sponsor name | University of Edinburgh (UK) |
| Sponsor details | Royal Infirmary
Little France
Edinburgh
United Kingdom
EH16 4SB |
| Sponsor email | mvm@ed.ac.uk |
| Sponsor website | http://www.ed.ac.uk/ |
| Contact name | Prof Peter Hayes |
| Contact details | Department of Hepatology
University of Edinburgh
Little France
Edinburgh
United Kingdom
EH16 4SA |
| Contact telephone | +44 (0)131 242 1625 |
| Contact email | p.hayes@ed.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN26269039 |
| Date last extracted from ISRCTN register | 17/04/2008 |
