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Clinical Trials Units

Leicester Clinical Trials Unit

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Areas of Research

  • Phase 1, 2, 3 and 4
  • Long-term surveillance/ population/epidemiology studies
  • Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
  • Clinical Trials of an Investigational Medical Product (CTIMP)
  • Studies to support UK regulatory approval
  • Studies to support international regulatory approval
  • Studies involving recruitment outside the UK

Sponsorship

We can take the sponsorship role but have flexibility

Particular areas of interest or experience in cardiovascular trial design and delivery

We have experience in planning and conducting a range of cardiovascular trials from single site early phase trials looking at safety and efficacy to large multi-site late phase trials looking at effectiveness. Trial settings include primary and secondary care, recruiting throughout the UK and also more recently to include international collaboration. With large trials we focus on ensuring the design is pragmatic and use routine data collection where possible. A number of our trials also include sub studies providing further significant outputs. Our portfolio includes major cardiovascular studies in management of myocardial infarction, treatment pathway of aortic stenosis and outcomes of cardiac surgery.
In addition to the clinical cardiovascular expertise of our director, we also have statistical and trial management expertise in areas including cluster trials, umbrella trials and platform trials.

  • EASY-AS : A Randomised Controlled Trial of Early valve replacement in severe ASYmptomatic Aortic Stenosis.
    ClinicalTrials.gov link: https://www.clinicaltrials.gov/ct2/show/NCT04204915
  • PHAST: Peripheral arterial disease, High blood pressure and Aneurysm Screening Trial (PHAST) – An evaluation of the acceptability, effectiveness and cost effectiveness of screening for peripheral arterial disease and high blood pressure at the same time as abdominal aortic aneurysm. This study is funded by the NIHR and has been designed with the help of men who have been through the AAA screening process.
    The PHAST Study is a multicentre, UK-based study, with the aim of finding out whether screening for peripheral arterial disease (PAD) and high blood pressure (BP) at the same time as screening for abdominal aortic aneurysms (AAA) improves cardiovascular health.
    Currently, 30% to 40% of people over the age of 65 have PAD and/or high BP. At least one-third of these people don’t know that they have these conditions. People who do have these conditions are at high risk of heart attacks, strokes and other cardiovascular problems.
    This study will identify the best devices for testing PAD and BP and then take these forward into screening. Where applicable, these tests will be combined with the AAA screening programme that is already in place nationally. We will be asking both researchers and participants about their experience of the additional screening tests.
    The most appropriate device or devices will be determined via a systematic review and assessments by experts in this field. The study will then initially be conducted as a mixed methods feasibility study, in which approximately 3000 men and 3000 women will be asked to undergo PAD and BP screening. For men this will be alongside the standard AAA screening pathway. As women are not invited for AAA screening due to low incidence, the BP and PAD assessments will not form part of any other screening programme. Suitable participants will be asked if they would like to contribute to qualitative and follow up sub-studies.
    The feasibility will inform the final part of the PHAST study: a cluster randomised crossover trial which will randomised PAD+BP+AAA screening to AAA screening only. Screening units will recruit for two years and we hope to recruit 260,640 participants. Participants will be followed up for three years for cardiac and limb events.
  • RAPID NSTEMI: A randomised controlled trial of very early angiography +/- intervention versus standard of care on outcomes in patients with non ST-elevation myocardial infarction
    Very Early Versus Delayed Angiography +/- Intervention on Outcomes in Patients With NSTEMI
  • REVAKI-2: Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial
    ISRCTN – ISRCTN18386427: The effect of sildenafil (REVATIO®) on post cardiac surgery acute kidney injury
  • REVAKI 1: A Phase I Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of Sildenafil (REVATIO®) in Cardiac Surgery: The REVAKI-1 Study. ClinicalTrials.gov (NCT02136329). https://clinicaltrials.gov/ct2/show/NCT02136329

Address: Leicester Clinical Trials Unit, College of Life Sciences, University of Leicester, Maurice Shock Building, University Road, Leicester LE1 7RH 

Telephone number: +44 (0)116 229 7246

Email address: ctu@leicester.ac.uk

Websites: https://le.ac.uk/lctu, https://le.ac.uk/lctu/trials, https://le.ac.uk/lctu/publications