Date

2025-06-23

Protocol

Protocol changed

Item Changed

Secondary outcome

Previous Version

1.Recurrent ICH, ischaemic stroke, fatal or disabling stroke, mortality 2.MACE (major adverse cardiovascular [CV] events of CV death, non-fatal myocardial infarction, or non-fatal stroke) 3.Health-related quality of life (HRQoL) using the EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D) 4.Physical function (simplified modified Rankin scale [smRS]), 5.Cognitive impairment, defined by standard cut-points on the Montreal Cognitive Assessments (MoCA), and supplemented by the Brief Memory and Executive Test. [6 monthly from commencement for a total of 3 years]

Next Version

1.Recurrent ICH, ischaemic stroke, fatal or disabling stroke, mortality 2.MACE (major adverse cardiovascular [CV] events of CV death, non-fatal myocardial infarction, or non-fatal stroke) 3.Health-related quality of life using the EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-3L) 4.Physical function (on the simplified modified Rankin scale [smRS]) 5.Clinically significant cognitive impairment, defined in accordance with standard cut-points on the Montreal Cognitive Assessment (MoCA), and supplemented by the Brief Memory and Executive Test (BMET), together with functional impairment, assessed by the Quick Dementia Rating System (QDRS) and Short Form of the Informant Questionnaire on Cognitive Decline in the Elderly (Short IQCODE); components and overall cerebral small vessel disease (CSVD) burden as assessed by MRI; depression on the Patient Health Questionnaire – 9 (PHQ-9); medication adherence (self-report and pill counts); difference in SBP; safety (serious adverse events [SAEs]); and tolerability (adverse events of special interest [AESI]) [1.1-4 = 6 monthly from commencement for 5-10 years; 2.5 = at Month 72 and End of study]