OptimiZation Of lipid lowering therapies using a DSS in ACS - ZODIAC
Research type
Research Study
Full title
Implementation of a Decision Support System and its effect on early optimisation of Lipid-Lowering Therapies in patients with Acute Coronary Syndrome: a cluster Randomised Controlled Trial
IRAS ID
317589
Contact name
Kausik K Ray
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 29 days
Research summary
Clinicians should prescribe appropriate treatments for Atherosclerotic Cardiovascular Disease (ASCVD) in accordance with expert guidelines, yet in current practice Lipid Lowering Therapies (LLTs) are often initiated later and with less potent single or combination therapies than recommended.
Imperial College London has developed a Decision Support System (DSS) which – after inputting various patient values - visualises the projected cardiovascular (CV) disease risk with single or combination therapies over time for adults (aged 18 - 80 years) with Acute Coronary Syndrome (ACS) who have recently been hospitalised (within 72 hours).
The study aims to assess whether the availability of the DSS compared to routine care alone results in an increased initiation or intensification of combination LLTs over a 24-week period after an ACS event.
This will be a cluster randomised trial with a total of 48 secondary care sites randomised to Standard of Care (SoC) [24 sites] or DSS [24 sites] across 3 countries: the United Kingdom (UK), Spain and Italy. There will be 16 sites per country; 8 DSS sites; 8 SoC sites. DSS sites will receive a standardised period of training prior to commencing patient recruitment. Participants will be followed up for a minimum of 24 weeks. Following the use of the DSS and regardless of its use, it is ultimately up to the clinical users to choose and prescribe a suitable therapy for their patients based on their clinical knowledge.REC name
South East Scotland REC 02
REC reference
22/SS/0106
Date of REC Opinion
19 Dec 2022
REC opinion
Favourable Opinion