| Source of record | UK Trials |
| ISRCTN | ISRCTN41194621 |
| Date ISRCTN assigned | 06/04/2000 |
| Local reference number(s) | E185/124 |
| Public title | Randomised controlled trial of bezafibrate in patients with lower extremity arterial disease (LEAD) |
| Scientific title |
|
| Acronym | LEADER trial |
| Disease/condition/study domain | Cardiovascular |
| Study hypothesis | Bezafibrate reduces primary end point by 30%. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Males with LEAD (no upper or lower age limit) |
| Participants - exclusion criteria | 1. Already on lipid-modifying agent
2. Renal or hepatic disease (including raised creatinine concentration)
3. Unstable angina; malignant disease
4. Serious intercurrent illness |
| Patient information material |
|
| Anticipated start date | 01/05/1992 |
| Anticipated end date | 30/09/2001 |
| Status of trial | Completed |
| Target number of participants | 1568 men recruited through 85 practices in the Medical Research |
| Interventions | Bezafibrate/control |
| Primary outcome measure(s) | Coronary heart disease events and strokes combined |
| Secondary outcome measure(s) | Fatal and non-fatal coronary events separately |
| Publications | T.W. Meade for the British Medical Council General Practive Research Framework and participating vascular clinics. Design and intermediate results of the Lower Extremity Arterial Disease Event Reduction (LEADER) trial of bezafibrate in men with lower extremity arterial disease. [ISRCTN4119421] Curr Control Trials Cardiovasc Med, 2001;2:195-204.
T.W. Meade, R. Zuhrie, C. Cook, J. Cooper. Bezafibrate in men with lower extremity arterial disease: randomised controlled trial. [ISRCTN4119421] BMJ, 2002;325:1139-1141. |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Prof TW Meade |
| Contact details | Non-communicable Disease Epidemiology Unit
Department of Epidemiology and Population Health
London School of Hygiene and Tropical Medicine
Keppel Street
London
United Kingdom
WC1E 7HT |
| Contact telephone | +44 (0)20 7927 2182 |
| Contact fax | +44 (0)20 7580 6897 |
| Contact email | tom.meade@lshtm.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN41194621 |
| Date last extracted from ISRCTN register | 17/04/2008 |
