N/A N=42 Randomized Single-blind Treatment

Safety of DS-1040b in Acute Ischemic Stroke Patients Treated With Thrombectomy

Acute Ischemic Stroke

Bottom Line

View on ClinicalTrials.gov: NCT03198715 ↗

Enrolled (actual)

Serious AEs

12.2%

Results posted

Jan 2021

Primary outcome: Primary: 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 — 0; 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: DS1040b (Drug); Placebo (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Daiichi Sankyo Co., Ltd.
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	0; 0; 0; 0; 0; 2	—
PRIMARY Number of Participants With Non-ICH Major Bleeding Within 96 Hours From Start of Treatment With DS-1040b In Acute Ischemic Stroke Participants	0; 0; 0; 0; 0	—
SECONDARY Pharmacokinetic Analysis Area Under The Plasma Concentration Time Curve (AUC) of DS-1040a in Plasma	111; 275; 570; 1550	—
SECONDARY Pharmacokinetic Analysis Maximum Concentration (Cmax) of DS-1040a in Plasma	17.2; 29.7; 60.6; 141	—
SECONDARY Pharmacokinetic Analysis Time to Maximum Concentration (Tmax) of DS-1040b in Plasma	2.21; 4.67; 5.11; 5.96	—
SECONDARY Pharmacokinetic Analysis Terminal Half-Life (T1/2) of DS-1040b in Plasma	4.61; 16.8; 19.5; 29.7	—
SECONDARY Pharmacokinetic Analysis Mean Amount of DS-1040a Excreted in Urine in Acute Ischemic Stroke Participants	0.420; 0.880; 1.49; 3.45	—
SECONDARY Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants	99.17; 80.05; 79.56; 81.90; 88.28; 94.05	—
SECONDARY Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants	1.600; 0.730; 2.423; 0.613; 3.096; 1.368	—
SECONDARY Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants	104.5; 81.8; 93.9; 99.0; 88.7; 110.4	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Is an acute ischemic stroke patients with evidence of intracranial vascular occlusion
Is enrolled in principle within 8 hours of symptom onset
Has treatment plan that includes stent retriever
Has protocol-defined scores on several scales

Exclusion Criteria

Has treatment plan that includes fibrinolysis or fibinolysis
Has identified intracranial hemorrhage or subarachnoid hemorrhage
Has active bleeding like gastrointestinal hemorrhage
Has cerebral bleeding risk; intracranial tumor, brain aneurysm, cerebral arteriovenous malformation, or history of intracranial bleeding
Has severe hepatic or renal impairment
Has been a participant in other clinical trial within 30 days prior to treatment
Is pregnant, lactating, or planning on becoming pregnant during treatment period
Has any condition or history that might, per protocol or in the opinion of the investigator, compromise:
safety or well-being of the participant or their offspring
safety of the study staff
analysis of results

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03198715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.