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Tests treatment safety and results for Acute Ischemic Stroke
Official title Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT05686642
What this study is testing
What is LT3001 Drug:high dose?
LT3001 Drug:high dose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- people aged between 18 and 80 years at screening;
- Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 3.4 points ≤ NIHSS score ≤ 25 points at randomization...
You likely can't join if
- people have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapy recommended by Chinese Guidelines for...
- Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
- Neurological signs have improved rapidly and spontaneously at screening;
- people who have used or are using protocol-prohibited medications after the onset;
- people with pre-stroke disability;
- people with intracranial hemorrhagic diseases, tumor in brain parenchyma, arteriovenous malformation, aortic arch dissection, other central nervous...
See the full eligibility criteria
- people aged between 18 and 80 years at screening;
- Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 3.4 points ≤ NIHSS score ≤ 25 points at randomization; 4.people who are able to receive the investigational drug within 24 hours...
- people have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapy recommended by Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018 during this onset period;
- Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
- Neurological signs have improved rapidly and spontaneously at screening;
- people who have used or are using protocol-prohibited medications after the onset;
- people with pre-stroke disability;
- people with intracranial hemorrhagic diseases, tumor in brain parenchyma, arteriovenous malformation, aortic arch dissection, other central nervous system lesions that may increase the risk of hemorrhage, or imaging...
- Massive infarction on imaging;
- Patients who are unable to cooperate due to epileptic seizure at the onset of stroke or other concomitant mental disorders or are unwilling to cooperate;
- Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg after active antihypertensive therapy;
- Acute hemorrhage tendency;
- Blood glucose level \ 400 mg/dL;
- Active visceral hemorrhage;
- Lactating or pregnant people, or women of childbearing potential with positive pregnancy test results;
- International normalized ratio \> 1.7 or prothrombin time \> 15 s;
- people with a history of serious hypersensitivity;
- people who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening;
- people who underwent any major surgery before screening;
- people with a history of active digestive ulcer before screening;
- people who experienced hemorrhagic disease before screening;
- people who underwent arterial puncture at the site not easy for hemostasis by compression before screening;
- Serious hepatic impairment or serious renal insufficiency;
- people who have participated in another investigational study and used investigational product before screening;
- Other conditions unsuitable for participation in this study determined by the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Luoyang, He'nan, China
- Hengshui, Hebei, China
- Daqing, Heilongjiang, China
- Wuhan, Hubei, China
- Baotou, Inner Mongolia, China
- Huai'an, Jiangsu, China
- Suzhou, Jiangsu, China
- Xuzhou, Jiangsu, China
- Pingxiang, Jiangxi, China
- Changchun, Jilin, China
- Chaoyang, Liaoning, China
- Liaocheng, Shandong, China
- Xianyang, Shanxi, China
- Xi’an, Shanxi, China
- Mianyang, Sichuan, China
- Hangzhou, Zhejiang, China
- Taizhou, Zhejiang, China
- Beijing, China
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Luoyang, He'nan, China; Hengshui, Hebei, China; Daqing, Heilongjiang, China; Wuhan, Hubei, China and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.