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

• Status: Completed
• Trial end date: 2020-01-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Pharmaceutical Solutions

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:

1. safety or well-being of the participant or their offspring

2. safety of the study staff

3. analysis of results