Table 2.
Participant schedule.
Activity |
Run-in phase |
Treatment phase |
|||||||
---|---|---|---|---|---|---|---|---|---|
Day 0 | Week 4 | Week 0 | Week 4 | Week 13 | Week 26 | Week 52 | Week 78 | Week 104 | |
Review eligibility | ✓ | ✓ | |||||||
Informed consent | ✓ | ||||||||
Optimise preventative therapy | ✓ | ||||||||
Clinical evaluationa | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Safety blood testsb | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Blood for uric acid level | ✓ | ✓ | |||||||
Blood/urine for biobanking | ✓ | ✓ | |||||||
ECG | ✓ | ✓ | |||||||
Echocardiography | ✓ | ||||||||
Determine cardiac sub-study eligibility | ✓ | ||||||||
MRI brain (± carotid MRI) | ✓ | ✓ | |||||||
ABPM | ✓ | ✓ | ✓ | ||||||
Cardiac MRI,c n=100 | ✓ | ✓ | |||||||
Detailed cognitive function evaluation | ✓ | ✓ | |||||||
Assessment of run in completion | ✓ | ||||||||
Randomisation | ✓ | ||||||||
Dispense | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Return/count IMP | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Adverse event review | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Note that the run in week 4 and treatment phase week 0 visits can take place concurrently. Participants will also be contacted by telephone at week 105, which marks the end of the study.
IMP: investigational medicinal product; ABPM: ambulatory blood pressure monitoring; ECG: electrocardiography; MRI: magnetic resonance imaging.
aMeasures of stroke severity at week 4, modified Rankin scale score and MoCA at week 52 and blood pressure at all visits except week 78 and weight at week 104).
bFBC, U + E, LFTs.
cSub-study eligible participants only.