Randomized Evaluation of fleCAinide safety vs. STandard of care in patients with coronary artery disease and Atrial Fibrillation (ReCAST AF).

Atrial fibrillation, Coronary artery disease

A composite safety outcome including the following adverse events of interest: (1) All-cause mortality; (2) Severe adverse events leading to drug discontinuation; and (3) Unscheduled hospitalisation for heart failure or acute coronary syndrome

Individual components of the primary safety endpoint, Freedom from fast atrial arrhythmia post-treatment (clinical recurrence of AF), Major adverse cardiovascular events (MACE): cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, Incidence of catheter ablation for AF during follow-up, Total number of days of cardiovascular hospitalisation, All adverse and serious adverse events (frequency and severity, proportion of participants experiencing at least one AE/SAE, specific drug-related adverse events), Changes in cardiac function from baseline to follow-up (left ventricular ejection fraction, global longitudinal strain, left atrial volume index), Change in N-terminal-pro-brain Natriuretic Peptide (NT-proBNP) from baseline, Change in QTc interval (ms) and QRS duration (ms) from baseline., Patient-reported outcome measures, including: Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire; EuroQoL-5 dimension health utility index (EQ-5D-5L); Short Form-12 (SF-12) health survey; EHRA symptom score; Work Productivity and Activity Impairment (WPAI) questionnaire, Economic evaluation with within-trial healthcare resource utilization between the two treatment arms

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