Table 1.
Study schedule.
| Activity/assessment | Screening–21 to 0 | BaselineDay 0 | Visit 1≥Day 28 | Visit 2≥Day 56 | Visit 3≥Day 84 |
|---|---|---|---|---|---|
| Informed consent | X | ||||
| Eligibility criteria | X | ||||
| Demographics | X | ||||
| Medical/history | X | X | |||
| Vital signs | X | X | X | X | |
| Physical exam | X | X | X | X | |
| Cognitive assessment | X | ||||
| Pregnancy test | (X) | (X) | (X) | (X) | (X) |
| Laboratory tests | X | X | X | X | X |
| ECG | X | ||||
| Randomisation | X | ||||
| 7 days home BP monitoring twice daily for 1 week | X | X | X | X | |
| Study drug dispensation | X | X | X | ||
| mRS (disability) | X | ||||
| NIHSS (stroke severity) only for stroke patients | X | ||||
| Drug accountability | X | X | X | ||
| Concomitant medication | X | X | X | X | X |
| Adverse events (AE) | X | X | X | ||
| Pulse wave velocity/pulse wave analysis | X | X | X | X | |
| Transcranial (TCD) ultrasound scan | X | X | X | X | |
| Beat-to-beat BP monitoring | X | X | X | X | |
| Peripheral vascular reactivity | X | X | X | X | |
| MRI assessment (up to 60 patients) | X | X | X |