A Multicenter, Prospective, Randomized, Open-label Phase 2b Study, with Blinded Evaluation, Comparing the Combination of Amodiaquine and Potassium Canrenoate with Either Exenatide or Glibenclamide Versus Best Medical Therapy, in Patients with Acute Ischemic Stroke

Conditions

Acute Ischemic Stroke

Brief summary

Percentage of patients with hemorrhagic transformation as depicted in a CT or MRI.

Detailed description

Degree of disability based on the mRS score, • Infarct volume defined as MRI lesion volume on Day 5 • Infarct volume defined as MRI lesion volume on Day 90 • Change in DWI lesion volume from Day 5 to Day 90, based on MRI • Change in PWI lesion volume from Day 5 to Day 90, based on MRI, Change in recanalization of the occluded vessel based on MR angiography (MRA)., Percentage of patients with clinically meaningful improvement in NIHSS score (improvement >4 points)., • Percentage of patients treated with investigational combination therapy on top of BMT and those treated with BMT only, experiencing all-cause on-treatment AEs, analyzed for: o patients that complete the study period, and o patients who discontinue from the study period due to an AE. • Percentage of patients with abnormal clinically significant laboratory test results., All-cause mortality., • Percentage of patients who developed depression, defined as score >10 on the HAM-D17 • Percentage of patients who developed mild to moderate depression (HAM-D17 score: 14-17), or moderate to severe depression (HAM-D17 score: >17)., Percentage of change in blood biomarkers., • Observed plasma concentration • Minimum observed plasma concentration at steady state conditions, Correlation of plasma concentrations of the investigational combination treatments with: • The percentage of patients experiencing overall AEs and specific AEs • Degree of disability based on the mRS score • The percentage of patients who developed depression • The percentage of patients with clinically meaningful improvement in NIHSS score • MRI response parameters • Biomarker levels • Treatment compliance

Related papers

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Interventions

DRUGExenatide 3.5μg/mL solution for subcutaneous injection

DRUGPotassium canrenoate 5mg/mL solution for intravenous injection

DRUGAmodiaquine+Glibenclamide (10mg+0.1mg) /5mL oral suspension

DRUGAmodiaquine 2mg/mL solution for intravenous injection

DRUGPotassium canrenoate 25mg/5mL oral suspension

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of patients with hemorrhagic transformation as depicted in a CT or MRI.	—

Secondary

Measure	Time frame
Degree of disability based on the mRS score, • Infarct volume defined as MRI lesion volume on Day 5 • Infarct volume defined as MRI lesion volume on Day 90 • Change in DWI lesion volume from Day 5 to Day 90, based on MRI • Change in PWI lesion volume from Day 5 to Day 90, based on MRI, Change in recanalization of the occluded vessel based on MR angiography (MRA)., Percentage of patients with clinically meaningful improvement in NIHSS score (improvement >4 points)., • Percentage of patients treated with investigational combination therapy on top of BMT and those treated with BMT only, experiencing all-cause on-treatment AEs, analyzed for: o patients that complete the study period, and o patients who discontinue from the study period due to an AE. • Percentage of patients with abnormal clinically significant laboratory test results., All-cause mortality., • Percentage of patients who developed depression, defined as score >10 on the HAM-D17 • Percentage of patients who developed mild	—

Measure

Time frame

Degree of disability based on the mRS score, • Infarct volume defined as MRI lesion volume on Day 5 • Infarct volume defined as MRI lesion volume on Day 90 • Change in DWI lesion volume from Day 5 to Day 90, based on MRI • Change in PWI lesion volume from Day 5 to Day 90, based on MRI, Change in recanalization of the occluded vessel based on MR angiography (MRA)., Percentage of patients with clinically meaningful improvement in NIHSS score (improvement >4 points)., • Percentage of patients treated with investigational combination therapy on top of BMT and those treated with BMT only, experiencing all-cause on-treatment AEs, analyzed for: o patients that complete the study period, and o patients who discontinue from the study period due to an AE. • Percentage of patients with abnormal clinically significant laboratory test results., All-cause mortality., • Percentage of patients who developed depression, defined as score >10 on the HAM-D17 • Percentage of patients who developed mild

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Outcome results

None listed