Evaluating LT3001 for treating acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical study aims to assess the safety and efficacy of LT3001 in patients suffering from acute ischemic stroke. Participants will receive either a high dose of LT3001, a low dose of LT3001, or a placebo within 24 hours of stroke onset. The study will measure neurological impairment using the NIHSS score to determine the drug's effectiveness. The trial is designed to provide insights into how LT3001 can improve outcomes for stroke patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects aged between 18 and 80 years at screening;
2. Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 3.4 points ≤ NIHSS score ≤ 25 points at randomization;

4.Subjects who are able to receive the investigational drug within 24 hours after the onset of stroke; 5.Female subjects of childbearing potential or male subjects whose sexual partner are women of childbearing potential have no pregnancy plan and voluntarily take effective contraceptive measures during the study period and for 3 months after the last dose; 6.All subjects sign the informed consent form by themselves or their guardians after receiving complete study information.

Exclusion Criteria:

1. Subjects 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;
2. Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
3. Neurological signs have improved rapidly and spontaneously at screening;
4. Subjects who have used or are using protocol-prohibited medications after the onset;
5. Subjects with pre-stroke disability;
6. Subjects 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 evidence for arterial aneurysm requiring treatment;
7. Massive infarction on imaging;
8. 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;
9. Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg after active antihypertensive therapy;
10. Acute hemorrhage tendency;
11. Blood glucose level \< 50 mg/dL or \> 400 mg/dL;
12. Active visceral hemorrhage;
13. Lactating or pregnant subjects, or women of childbearing potential with positive pregnancy test results;
14. International normalized ratio \> 1.7 or prothrombin time \> 15 s;
15. Subjects with a history of serious hypersensitivity;
16. Subjects who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening;
17. Subjects who underwent any major surgery before screening;
18. Subjects with a history of active digestive ulcer before screening;
19. Subjects who experienced hemorrhagic disease before screening;
20. Subjects who underwent arterial puncture at the site not easy for hemostasis by compression before screening;
21. Serious hepatic impairment or serious renal insufficiency;
22. Subjects who have participated in another investigational study and used investigational product before screening;
23. Other conditions unsuitable for participation in this study determined by the Investigator.

Where it's running

• Beijing Luhe Hospital Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Jinan University
  Guangzhou, Guangdong, China Recruiting
• Luoyang Third People's Hospital
  Luoyang, He'nan, China Recruiting
• Harrison International Peace Hospital
  Hengshui, Hebei, China Recruiting
• Daqing Oilfield General Hospital
  Daqing, Heilongjiang, China Recruiting
• Zhongnan Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Yongjun Wang
• Email: Yongjunwang111@aliyun.com
• Phone: 0086-010-59978538

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Safety of adding NRICM301 to standard care for adults with acute ischemic stroke

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• Intracranial Recanalization with LT3001 in Acute Ischemic Stroke

  This phase II study tests whether LT3001 given to adults with acute ischemic stroke can help reopen blocked brain arteries.

  Recruiting Phase 2 Lumosa Therapeutics Co., Ltd. · Taichung · NCT07890298

• Mobilisation After Endovascular Stroke Treatment

  This study checks whether moving around 12 hours after endovascular stroke treatment is as safe as moving around 24 hours for people with an acute ischemic stroke.

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• Endovascular therapy plus standard care vs standard care alone for distal and medium vessel strokes

  In people with acute ischemic stroke due to distal or medium vessel blockages, this study tests whether adding endovascular treatment to the usual medical care helps improve outcomes compared with medical care alone.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT07843797

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.