Table 2.
Schedule of events.
| Assessments | Baseline information–study allocation | Thrombectomy | Follow up 24 h | Follow up 48 h | Follow up 72 h | Follow up 90 days |
|---|---|---|---|---|---|---|
| Admission details | X | |||||
| Demographics and physical examination | X | |||||
| Medical history and baseline medication | X | |||||
| Eligibility criteria | X | |||||
| Informed consent | X | |||||
| Vital sings (BP, HR, BT) | X | X | X | X | ||
| mRS | X | X | X | |||
| NIHSS | X | X | X | 2X1 | X | |
| Pregnancy test | X | |||||
| Randomization | X | |||||
| Blinded study medication administration | X | |||||
| Monitorization of study medication site of injection | X | X | X | X | X | |
| Blood test: Hematology and biochemistry including INR | X | X | ||||
| Blood test: aPTT, PCR and complement activation | X | X | X | X | ||
| Proinflammatory biomarkers in blood (Phase Ib) | 3X2 | X2 | X2 | X2 | ||
| Proinflammatory biomarkers (Phase IIa) | 2X2 | X2 | X2 | X2 | ||
| Pharmacokinetics (in Phase Ib) | 3X3 | X3 | X3 | X3 | ||
| Urine analysis for elimination assessment (in Phase Ib) | X4 | X4 | ||||
| ECG | X5 | X | X | X | ||
| Non-contrast CT | X | X | ||||
| CTA | X | |||||
| CT-P | X | |||||
| DWI-MRI | X6 | |||||
| FLAIR-MRI | X | X7 | ||||
| EVT details8 | X | |||||
| Angiogram | X | |||||
| Stroke etiology | X9 | |||||
| EuroQol EQ-5D | X | |||||
| Relevant meds | X | X | X | X | X | X |
| Adverse events | X | X | X | X | X | X |
X1, NIHSS should also be performed on day 5 or discharge (whatever occurs first).
X2, In Phase Ib, proinflammatory biomarker samples should be taken at pre-dose, and at the end of the infusion (up to 1 h), 6, 24, 48, and 72 h post-dose. In Phase IIa, proinflammatory biomarkers will be analyzed at pre-dose and 6, 24, 48, and 72 h post-dose.
X3, Pharmacokinetic samples should be taken at pre-dose, and at the end of infusion (up to 1 h), 6, 24, 48, and 72 h from the end of infusion.
X4, Collect, if possible, urine samples from the study drug administration for 24 h.
X5, First ECG should be performed at 6 h post-dose.
X6, Included only in those hospitals where the inclusion is performed based on MRI criteria (i.e., France).
X7, Only for sites participating in image sub-study.
EVT8, Groin puncture should be done before 8 h after symptoms onset. For wake-up strokes, onset time will be considered as the time of symptoms first discovered.
X9, Stroke etiology will be completed when available.