Study period | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Visit description | Enrollment | Allocation | Intervention | Postoperation | Discharge | Close-out | ||||
Visit number | V1 | V2 | V3 | V4 | V5 | V6 | V7 | V8 | ||
Timepoint | − 72h~0 | 0h±2h | 6h±2h | 24h±6h | 48h±6h | 72h±6h | 7 days ± 3 days | 30 days ± 5 days | ||
Enrollment: | ||||||||||
Eligibility screen | X | |||||||||
Informed consent | X | |||||||||
Allocation | X | |||||||||
Intervention: | ||||||||||
Evolocumab administration | X | |||||||||
No medication | X | |||||||||
Assessment: | ||||||||||
Demographics | X | |||||||||
Medical history | X | |||||||||
Vital signs, physical dataa | X | X | X | X | X | X | X | X | ||
Urine HCG | X | |||||||||
ECGb | X | X | X | X | X | |||||
Laboratory tests | X | X | X | X | X | X | X | |||
Concomitant drug | X | X | X | X | X | X | X | X | ||
Outcome variablesc | X | X | X | X | X | X | X | |||
Transthoracic echocardiography | X | X | ||||||||
Clinical resultsd, safety evaluation | X | X | X | X | X | X | X | X |