Table 2.
Schedule of evaluations for participants who will be undertaking advanced arterial studies
| Study periods | Screening | Baseline | Randomisation | Treatment | ||
| Study week | Week −3 | Week −2 | Week 0 | Week 4 | Week 12 (end of treatment) |
Week 16 (end of study) |
| Study visit window from randomisation | ±21 days | ±14 days | N/A | ±7 days | ±7 days | ±7 days |
| Study visit number (as per patient consent form) |
1 | 2 | 3 and 4 | 5 | 6, 7 and 8 | |
| Evaluation | ||||||
| Informed consent | X | |||||
| Inclusion/exclusion criteria | X | X | X | |||
| Demographics (DOB, sex, ethnicity) | X | |||||
| Physical examination (abdomen, cardiovascular, mental status, respiratory, peripheral oedema) | X | X | X | |||
| Medical History | X | |||||
| Vital signs (height, weight, BMI, heart rate, BP*3) | X | X | X | |||
| 12-lead ECG | X | X | X | |||
| Concomitant medications | X | X | X | X | ||
| Randomisation | X | |||||
| Prescription | X | X | ||||
| Study drug or placebo dispensed | X | X | ||||
| Study drug returns and pill counts | X | X | ||||
| Patient diary | X | X | X | |||
| Quality of life questionnaires (SF-36, EQ-5D-5L, Intermittent Claudication Questionnaire) | X | X | ||||
| Wearable technology (measure of daily activities for 4 days) | X | X | ||||
| Cardiovascular-related adverse events reporting | X | X | X | |||
| Other AE/AESI/SAEs | X | X | X | |||
| Pathology blood tests (FBC, EUC, LFT, HbA1c, fasting lipids-TC, LDL, HDL, TG)* | X | X1 | X | |||
| Research blood sample collection (Laboratory assessments) | X | X | ||||
| ABI | X | X | ||||
| PWT | X | X | X | |||
| Advanced arterial studies (MRI flow and perfusion; brachial arterial reactivity)† | X | X | ||||
| Phone follow-up (general health condition) | X | |||||
*Only FBC, EUC, LFT will be tested at the week 4 visit.
†Advanced arterial studies will be conducted in a subset of patients enrolled at participating sites.
ABI, ankle-brachial index; AE, adverse event; AESI, adverse events of special interest; BMI, body mass index; DOB, date of birth; ECG, electrocardiogram; EQ-5D-5L, EuroQol-5 Dimension-5 Level; EUC, electrolytes urea creatinine (renal function tests); FBC, full blood count; HbA1c, haemoglobin A1c; HDL, high-density lipoprotein; LDL, low-density lipoprotein; LFT, liver function tests; MRI, magnetic resonance imaging; PWT, peak walk time; SAE, serious adverse event; SF-36, 36-Item Short Form Survey; TC, total cholesterol; TG, triglycerides.