20,000
Participants
Start Date
September 26, 2024
Primary Completion Date
September 30, 2034
Study Completion Date
September 30, 2034
Standard-dose intravenous tenecteplase
Standard-dose intravenous tenecteplase (0.25 mg/kg body weight); one-time IV bolus injection soon after randomisation
Low-dose intravenous tenecteplase
Low-dose intravenous tenecteplase (0.18 mg/kg body weight); one-time IV bolus injection soon after randomisation
No intravenous tenecteplase
No intravenous tenecteplase only in subjects on direct oral anticoagulant (DOACs) or those planned for emergency endovascular thrombectomy (EVT)
Conservative Blood Pressure Control
No or minimal Systolic Blood Pressure (SBP) control; SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP (≥180mmHg); the timing of administration of interventions is specified to be immediately after randomisation; the intervention target is to be achieved ideally at 1 hour after randomisation and maintained for 24 hours (or until hospital discharge or death if this should occur earlier)
Moderate Blood Pressure Control
SBP reduction by 10-20mmHg or a target of 160 ± 5, whichever is higher; no control if low-high baseline SBP (150-160mmHg); the timing of administration of interventions is specified to be immediately after randomisation; the intervention target is to be achieved ideally at 1 hour after randomisation and maintained for 24 hours (or until hospital discharge or death if this should occur earlier)
Intensive Blood Pressure Control
SBP reduction by 30-50mmHg or a target of 140±5 mmHg, whichever is higher after endovascular thrombectomy (EVT); the timing of administration of interventions is specified to be immediately after randomisation; the intervention target is to be achieved ideally at 1 hour after randomisation and maintained for 24 hours (or until hospital discharge or death if this should occur earlier)
Placebo
100 mL of 0.9% normal saline, administered as a single IV infusion with a 20-minute dosing duration.
NoNO-42
NoNO-42 at weight-based dosing - 2.6 mg/Kg, administered as a single IV infusion with a 20-minute dosing duration
No deferoxamine mesylate and no colchicine
No deferoxamine mesylate and no colchicine
Deferoxamine mesylate only
Deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days
Colchicine only
0.5mg of oral colchicine daily for 30 days
Both deferoxamine mesylate and colchicine
Deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days; plus 0.5mg of oral colchicine daily for 30 consecutive days
RECRUITING
The George Institute for Global Health, Sydney
RECRUITING
University of Calgary, Calgary
Collaborators (1)
University of Calgary
OTHER
Berry Consultants
OTHER
The George Institute
OTHER