Everett CC, Fox KA, Reynolds C, Fernandez C, Sharples L, Stocken DD, Carruthers K, Hemingway H, Yan AT, Goodman SG, Brieger D, Chew DP, Gale CP.
BMJ Open (2019) 9(9): e025724
For non-ST-segment elevation acute coronary syndrome (NSTEACS) there is a gap between the use of class I guideline recommended therapies and clinical practice. The Global Registry of Acute Coronary Events (GRACE) risk score is recommended in international guidelines for the risk stratification of NSTEACS, but its impact on adherence to guideline-indicated treatments and reducing adverse clinical outcomes is unknown. The objective of the UK GRACE Risk Score Intervention Study (UKGRIS) trial is to assess the effectiveness of the GRACE risk score tool and associated treatment recommendations on the use of guideline-indicated care and clinical outcomes.
METHODS AND ANALYSIS:
The UKGRIS, a parallel-group cluster randomised registry-based controlled trial, will allocate hospitals in a 1:1 ratio to manage NSTEACS by standard care or according to the GRACE risk score and associated international guidelines. UKGRIS will recruit a minimum of 3000 patients from at least 30 English National Health Service hospitals and collect healthcare data from national electronic health records. The co-primary endpoints are the use of guideline-indicated therapies, and the composite of cardiovascular death, non-fatal myocardial infarction, new onset heart failure hospitalisation or cardiovascular readmission at 12 months. Secondary endpoints include duration of inpatient hospital stay over 12 months, EQ-5D-5L responses and utilities, unscheduled revascularisation and the components of the composite endpoint over 12 months follow-up.
ETHICS AND DISSEMINATION:
The study has ethical approval (North East – Tyne & Wear South Research Ethics Committee reference: 14/NE/1180). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the funder’s open access policy.
Clinical trials Day 2022: How data can make trials faster, more efficient and better at improving care
20 May 2022
We explore how routinely collected health data may hold the key to super-charging how clinical trials are delivered, and in turn, how quickly we can bring improvements to people's lives.
Accelerating research through data-enabled Clinical Trials
19 May 2022
Linking historic trial data with electronic health records allowed this dormant trial on the relationship between infant formula and cognitive ability to become reactivated - making it the first...