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 range
18 Years – 90 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.