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

A phase 1, single blind, placebo-controlled, randomized study to assess the safety of DS-1040b in subjects with thombectomy-treated acute ischemic stroke.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223556

Enrollment

Registered

2017-06-13

Start date

2017-07-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

investigational material(s) Generic name etc : DS-1040b INN of investigational material : - Therapeutic category code : 333 Anticoagulants Dosage and Administration for Investigational material : 4 co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 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

Design outcomes

Primary

Measure	Time frame
safety - The rate of Symptomatic ICH (definition of European Cooperative Acute Stroke Study[ECASS]) - The rate of Asymptomatic ICH - The rate of non-ICH major bleeding [definition of TIMI]	—

Secondary

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

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026