A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke

Condition studied

Acute Ischemic Stroke

Investigational medicinal product(s)

Eligibility

Primary endpoint

Parts A and B: Proportion of participants who develop symptomatic intracranial hemorrhage (sICH) within 120 hours after trial intervention, defined by the Heidelberg Bleeding Classification system.

Endpoint detail

Part A: Proportion of participants with treatment-related and unrelated treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) within 90 days. • Proportion of participants with severe TEAEs within 90 days. • Proportion of participants with life-threatening adverse events (AEs) within 90 days. • Proportion of participants with AEs of special interest (AESIs)., Part A continued: • Proportion of participants with clinically relevant changes in vital signs, clinical chemistry, and hematology. • Incidence of binding and neutralizing antibodies to ADAMTS13 from Day 30 to Day 90. • All-cause mortality within 90 days. • Proportion of participants with modified Rankin Scale (mRS) score of 0-1 at Day 90. • Proportion of participants with mRS score of 0-2 at Day 90. • Ordinal distribution of mRS at Day 90., Part A continued: • Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 hours. • Proportion of participants with recanalization at 24 hours, defined as complete recanalization with an arterial occlusive lesion (AOL) score of 3. • Proportion of participants with reperfusion at 24 hours, defined as >90% reduction in volume of reversible ischemic tissue (penumbra) from baseline. • Final infarct volume at 72 hours or discharge (if earlier than 72 hours)., Part B: • Proportion of participants with mRS score of 0-1 at Day 90. • Proportion of participants with mRS score of 0-2 at Day 90 • Ordinal distribution of mRS at Day 90. • Change in NIHSS score from baseline at 24 hours., Part B continued: • Proportion of participants with recanalization at 24 hours, defined as complete recanalization with an AOL score of 3. • Proportion of participants with reperfusion at 24 hours, defined as >90% reduction in volume of reversible ischemic tissue (penumbra) from baseline. • Final infarct volume at 72 hours or hospital discharge (if earlier than 72 hours).