| Screening phase | Study phase | ||||
---|---|---|---|---|---|---|
Evaluation | Screening | Follow-up | ||||
Time | −30 min | 0 | 1 hour (after PCI) | 24 hours (after PCI) | 1 week (after PCI) | 4 weeks (±3 days) (after PCI) |
Visit number | V0 | V1 | V2 | V3 | V4 | V5 |
Design | ||||||
Inclusion/exclusion criteria | x | Â | Â | Â | Â | Â |
Informed consent | x | Â | Â | Â | Â | Â |
Demographics | x | Â | Â | Â | Â | Â |
Medical/surgical history, allergy history, alcohol habits, smoking habits | x | Â | Â | Â | Â | Â |
Symptom inquiry | x | x | x | x | x | x |
Body weight | x | Â | Â | Â | Â | x |
Physical examination | x | x | x | x | x | x |
Vital signs: temperature/pulse/respiration/blood pressure | x | x | x | x | x | x |
18-lead ECG | x | x | x | x | x | x |
AE/SAE recording | x | x | x | x | x | x |
Treatment adherence | x | x | x | x | x | x |
Myocardial necrosis biomarkers | x | Â | Â | x | x | x |
Laboratory testing/efficacy | ||||||
CD40l/CRP/P-selectin/CECs | Â | x | Â | x | x | x |
Laboratory testing/safety | ||||||
Creatinine | Â | x | Â | x | x | x |
Uric acid | Â | Â | Â | x | x | x |
AST/ALT/TBIL | Â | Â | Â | x | x | x |
Blood-routine | Â | x | Â | x | x | x |
TG/TC/HDL-C/LDL-C | Â | Â | Â | x | x | x |
Serum Na+, K+, Cl− |  | x |  | x | x | x |
Urinary albumin | Â | Â | Â | x | Â | x |