Safety study of DS-1040b in acute ischemic stroke patients with thrombectomy

Phase 1

Completed

• Conditions: Acute ischemic stroke

• Registration Number: JPRN-jRCT2080223556
• Lead Sponsor: DAIICHI SANKYO CO., LTD.

Brief Summary

The objective of this study was to confirm the safety and tolerability of DS-1040b in patients with acute ischemic stroke in whom a thrombectomy device was indicated. There were no subjects who had symptomatic ICH and non-intracranial (TIMI) major bleeding. DS-1040b was safe and well tolerated with an overall safety profile similar to placebo.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-13
• Study Completion: 2020-01-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Female and male from 20 to 89 years old
2. Acute ischemic stroke patients with CTA or MRA evidence of intracranial vascular occlusion (ICA, MCA M1 division)
3. In principle within 8 hours of symptom onset
4. Treatment with stent retriever is planned
5. NIHSS >= 6, ASPECTS >= 6

Exclusion Criteria

1. Treated with fibrinolysis or fibrinolysis is planned
2. Intracranial hemorrhage or subarachnoid hemorrhage is identified by CT or MRI
3. Subjects have active bleeding like gastrointestinal hemorrhage
4. Subjects with cerebral bleeding risk; intracranial tumor, brain aneurysm, cerebral arteriovenous malformation, or history of intracranial bleeding
5. Subjects with aortic dissection
6. Subjects have had head trauma, spinal cord trauma, or intracranial surgery within 3 months
7. Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days
8. Subjects have had major surgery within 14 days or trauma
9. Subjects with an elevated APTT or PTT more than twice of normal range
10. INR > 1.7
11. Platelet < 100,000/mm3
12. Uncontrolled hypertension (SBP > 185 mmHg, DBP > 110 mmHg)
13. Blood glucose > 400 mg/dL
14. Subjects with more than two major artery occluded
15. Inadequate for treatment with stent retrievers, for example, carotid dissection, totally occluded carotid artery, or allergy for contrast agent
16. Severe hepatic impairment (fulminant hepatitis, cirrhosis, hepatophyma, TB >= 3.0 mg/dL, AST >= 2.5x ULN, ALT >= 2.5x ULN, ALP >= 2.5x ULN)
17. Severe renal impairment patients with chronic dialysis, nephrotic syndrome, acute renal failure, chronic renal failure, uremia, hydronephrosis, or serum creatinine >= 2.0 mg/dL
18. History of ischemic stroke within 30 days prior to treatment
19. Participant in other clinical trial within 30 days prior to treatment
20. Subject with pregnant, during lactation, planning on becoming pregnant during treatment period
21. Any other reason, in the opinion of the Investigator, which precludes subjects participation in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>- The rate of Symptomatic ICH (definition of European Cooperative Acute Stroke Study[ECASS])<br>- The rate of Asymptomatic ICH<br>- The rate of non-ICH major bleeding [definition of TIMI]

Secondary Outcome Measures

Name	Time	Method
efficacy<br>pharmacokinetics<br>pharmacodynamics<br>- Pharmacokinetics parameters of plasma and urine<br>- Biomarker related to the fibrinolysis activity (TAFIa activity, D-dimer, TAFI antigen volume)<br>- Change of NIHSS from baseline to 24 after administration of DS-1040b<br>- The rate of good clinical outcome (mRS 0-2) at Day 90