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

Daiichi Sankyo

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Drug: DS1040b; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03198715

DS1040-A-J110

173612 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 20 to 89 years old

Volunteers: No Healthy Volunteers

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:

  1. safety or well-being of the participant or their offspring
  2. safety of the study staff
  3. analysis of results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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42 participants in 5 patient groups, including a placebo group

DS-1040b 0.6 mg

Experimental group

Description:

Participants receive DS-1040b 0.6 mg by intravenous infusion over six hours

Treatment:

Drug: DS1040b

DS-1040b 1.2 mg

Experimental group

Description:

Participants receive DS-1040b 1.2 mg by intravenous infusion over six hours

Treatment:

Drug: DS1040b

DS-1040b 2.4 mg

Experimental group

Description:

Participants receive DS-1040b 2.4 mg by intravenous infusion over six hours

Treatment:

Drug: DS1040b

DS-1040b 4.8 mg

Experimental group

Description:

Participants receive DS-1040b 4.8 mg by intravenous infusion over six hours

Treatment:

Drug: DS1040b

Placebo

Placebo Comparator group

Description:

Participants receive saline by intravenous infusion over six hours

Treatment:

Drug: Placebo