Clinical Trial TitleASSENT
Clinical Trial Protocol Description:
The purpose of this study is to assess the safety and tolerability of DS-1040b, a thrombolytic agent (IV infusion over 6 hours) in subjects with acute ischemic stroke within 4.5 to 12 hours after stroke symptom onset time.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have a diagnosis of acute ischemic stroke confirmed by brain CT or MRI scan.
- Have an NIHSS score ≥ 2.
- Administration of the first dose of the study drug within 4.5 to 12 hours of symptom onset.
You will be excluded from the study if any of the following criteria apply to you:
- Are treated or anticipate treatment with tissue plasminogen activator (t-PA) and/or endovascular thrombectomy.
- Have evidence of intracranial or subarachnoid hemorrhage.
- Have a preexisting disability classified by mRS > 2.
- Have platelet count < 100,000, have an INR > 1.7, have a baseline hemoglobin < 10.5 g/dL, glomerular filtration rate < 60 mL/min/1.73 m2.
This is a partial list of inclusion and exclusion criteria.