The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by intravenous infusion for 6 hours. Groups with the lowest dose will start. When it is determined that each dose is safe and tolerable, the next higher dose will be given to the next group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
42
Hirosaki University Hospital
Hirosaki, Aomori, Japan
Funabashi Municipal Medical Center
Funabashi, Chiba, Japan
Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants
Symptomatic and asymptomatic intracranial hemorrhage (ICH) confirmed by head imaging (CT or MRI) are reported. Symptomatic ICH was defined as Intracranial hemorrhage with clinical deterioration causing an increase in the National Institutes of Health Stroke Scale (NIHSS) score of ≥ 4 points (defined by European Cooperative Acute Stroke Study). Asymptomatic ICH included the following: Hemorrhagic infarction type 1: Small petechial hemorrhage along the margins of the infarct, Hemorrhagic infarction type 2: Confluent petechial hemorrhage within the infarcted area, but without a mass effect, Parenchymal hematoma type 1: Hematoma involving ≤ 30% of the infarcted area with a slight mass effect, Parenchymal hematoma type 2: Hematoma involving \> 30% of, or outside the infarcted area, with a significant mass effect.
Time frame: From start of treatment up to 36 hours post single, intravenous dose
Number of Participants With Non-ICH Major Bleeding Within 96 Hours From Start of Treatment With DS-1040b In Acute Ischemic Stroke Participants
Non-ICH was defined as a clinically evident bleeding with a 5 g/dL or greater decrease in hemoglobin.
Time frame: From start of treatment up to 96 hours post single, intravenous dose
Pharmacokinetic Analysis Area Under The Plasma Concentration Time Curve (AUC) of DS-1040a in Plasma
The pharmacokinetic (PK) parameter of area under the plasma concentration-time curve up to the last quantifiable time was calculated using linear up logarithmic down rule.
Time frame: Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose
Pharmacokinetic Analysis Maximum Concentration (Cmax) of DS-1040a in Plasma
The PK parameter of maximum concentration (Cmax) was observed values.
Time frame: Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose
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Kokura Memorial Hospital
Kitakyushu, Fukuota, Japan
Mihara Memorial Hospital
Isesaki, Gunma, Japan
Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan
Japan Organization of Occupational Health and Safety Kansai Rosai Hospital
Amagasaki, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Hyogo College of Medicine College Hospital
Nishinomiya, Hyōgo, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Iwate Prefectural Central Hospital
Morioka, Iwate, Japan
...and 10 more locations
Pharmacokinetic Analysis Time to Maximum Concentration (Tmax) of DS-1040b in Plasma
The PK parameter of time to maximum concentration (Tmax) was observed values. When there are more than one time point, the time point when the concentration reached the first Cmax will be used as Tmax.
Time frame: Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose
Pharmacokinetic Analysis Terminal Half-Life (T1/2) of DS-1040b in Plasma
The PK parameter of terminal half-life (T1/2) was calculated from the following formula in participants whose Kel could be calculated. T1/2=ln2 / Kel
Time frame: Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose
Pharmacokinetic Analysis Mean Amount of DS-1040a Excreted in Urine in Acute Ischemic Stroke Participants
The pharmacokinetic parameter of amount of drug excreted in urine was calculated from the following formula: urine concentration (ng/mL) /10\^6× (urine weight / urinary specific gravity)
Time frame: From start of treatment up to 24 hours post single, intravenous dose
Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
The mean thrombin activatable fibrinolysis (TAFI) antigen levels and change from baseline in TAFI levels are reported. Change from baseline is based on the number of participants with baseline and at least one post-baseline laboratory test.
Time frame: Baseline, 6 hours and 24 hours post single, intravenous dose
Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
Mean D-dimer levels and change from baseline in D-dimer levels are reported.Change from baseline is based on the number of subjects with baseline and at least one post-baseline laboratory test.
Time frame: Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose
Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants
Mean activated form of thrombin-activatable fibrinolysis inhibitor (TAFIa) and change from baseline in TAFIa are reported. Change from baseline is based on the number of subjects with baseline and at least one post-baseline laboratory test.
Time frame: Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose