A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS (NCT04091945) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS
United States, Taiwan24 participantsStarted 2020-01-27
Plain-language summary
This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 to 90 years
* NIHSS of 4 to 30
* Diagnosis of AIS within 24 hours after stroke symptoms onset
Exclusion Criteria:
* Treatement with approved drug during the current AIS
* Pre-stroke disability
* Imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment
* Suspected subarachnoid hemorrhage
* Seizure
* Uncontrolled hypertension
* INR \>1.7 and/or abnormal aPTT or platelet count \<100,000/mm3
* Blood glucose concentration \<50 mg/dL or \>400 mg/dL
* Lactating or pregnant subjects or those planning to become pregnant during the study
* Received anticoagulants and/or antiplatelet therapy and glycoprotein IIb/IIIa inhibitors within 48 hours
* AIS, myocardial infarction, serious head trauma or major surgery within 90 days
* Bleeding event within 21 days
* Puncture of noncompressible vessels within 7 days
* Severe hepatic, renal, and/or infectious disease
What they're measuring
1
The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS.