Table 1.
Visit | Screening −10 to −6 weeks |
Run-ina −6 to 0 weeks |
Randomisation 0 weeks |
Follow-upb | |||
---|---|---|---|---|---|---|---|
3 monthly | 6 monthly | Annually | Finalc | ||||
Time window for evaluation | N/A | + 2 days | N/A | ±14 days | ±14 days | ±14 days | N/Ac |
Informed consent (prior to or at screening) | X | ||||||
Assessment of eligibility | X | ||||||
Demographics | X | ||||||
Anthropometrics—height and weight | X | Xf | Xf | ||||
Behavioural—smoking | X | ||||||
Medical history | X | ||||||
Concomitant medications | X | X | X | ||||
AAA imaging (standard care)h | X | X | X | ||||
Blood tests—creatinine, eGFR, HbA1c, CRP (if available), LDL-C (if available)d | X | Xg | Xg | ||||
Blood sample for biomarker sub-studye | X | Xe | X | ||||
QoL questionnaires: SF-36, AneurysmDQoL | X | X | X | ||||
Run-in medication dispensed | X | ||||||
Randomisation | X | ||||||
Study medication dispensed | X | X | X | ||||
Study medication adherence | X | X | X | X | X | ||
AESI reporting | X | X | X | X | X | ||
Serious adverse event reporting | X | X | X | X | X | ||
Assessment of exploratory outcomes not classified as SAEs (diagnosis of cancer, diagnosis of diabetes, symptomatic gout) | X | X | X | X | |||
Health economic assessment questions | X | X |
aParticipants will be contacted by telephone fortnightly during the 6-week run-in period
bParticipants will be contacted every 3 months after randomisation
cParticipants will undergo a final follow-up within 3 months of the date of the last adjudicated primary outcome event
dIf blood tests are available from within 6 months prior to screening, no need to repeat tests at screening
eOnly for participants who have consented to the biomarker sub-study. Samples will be collected at entry, at years 1 and 3, and at the final scheduled follow-up
fWeight only
geGFR only. If blood tests are available from within 3 months prior to annual follow-up/final follow-up, no need to repeat tests
hIf imaging is available within 12 months of screening/annual follow-up, no need to repeat tests