NCT06759753 Aleeto in Acute ISchemic Stroke：A RandomISed Controlled Clinical Trial
| NCT ID | NCT06759753 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 192 participants in total. It began in 2025-03-21 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a prospective, double-blind, 1:1:1 randomized controlled study aimed at evaluating the efficacy and safety of Aleeto treatment compared to placebo in improving the NIHSS score at 14 days in patients with moderate to severe acute ischemic stroke. It also aims to explore the neuroprotective effects of Aleeto in moderate to severe acute ischemic stroke and provide data support and evidence for future clinical trials and evidence-based medicine.
Eligibility Criteria
Inclusion Criteria: 1. Age between 30 and 80 years (30 ≤ age ≤ 80). 2. Diagnosis of acute ischemic stroke confirmed by CT or MRI, according to the "Key Points for Diagnosis of Major Cerebrovascular Diseases in China 2019." 3. Time from symptom onset ≤ 72 hours. 4. NIHSS score between 6 and 24, with a score of ≥ 1 on items 5 and 6 of the NIHSS. 5. Pre-stroke mRS (modified Rankin Scale) \< 2, indicating independent activities of daily living. 6. Signed informed consent. Exclusion Criteria: 1. Intracranial hemorrhagic diseases identified by head CT: cerebral hemorrhage, extradural hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc. 2. Combined with other active and major neurological diseases (such as induced seizures, poor drug control of recurrent seizures, multiple sclerosis, intracranial tumors, etc.). 3. History of infectious diseases (HIV positive or positive test history, HCV antibody positive or positive test history, HBV surface antigen positive and/or serum HBV DNA positive or serum HBV DNA \> 2 × 10\^8 IU/ml). 4. Severe renal or hepatic insufficiency. (Severe hepatic insufficiency is defined as alanine aminotransferase (ALT) value\>3 times normal upper limit or Aspartate aminotransferase (AST)\>3 times normal upper limit; Severe renal insufficiency is defined as creatinine\>1.5 times normal upper limit or creatinine clearance \< 50 ml/min, or over stage 3 of chronic kidney disease), severe heart failure (New York Heart Association grades III - IV). 5. Resistant Hypertension, systolic pressure ≥220mmHg or diastolic pressure ≥120mmHg. 6. History of Hemostatic disorder, systemic bleeding, thrombocytopenia or neutropenia, drug-induced hematology or liver dysfunction, white blood cell count \<2×10\^9/L or platelet count \<100×10\^9/L. 7. History of severe anemia within the past 1 month (hemoglobin \< 90g/L). 8. Body Mass Index (BMI) \< 16kg/m2 or BMI\> 35kg/m2. 9. Severe organic diseases with expected survival time \<5 years, such as malignant tumor. 10. Women of child bearing potential, pregnant or breastfeeding. 11. Individual who have difficulty communicating verbally to the extent that they are unable to communicate, understand or follow instructions normally, and are unable to cooperate with treatment and evaluation. 12. Combined with alcohol and drug abuse history. 13. Known history of allergy to biological agents such as proteins and cell products. 14. History of intracranial or spinal surgery, major surgery, or severe physical trauma within the past 4 weeks. 15. Received any vaccinations within the past 28 days. 16. Use of other investigational drugs within 30 days or 5 drug half-lives. 17. Unable to complete follow-up due to geographical or other reasons. 18. The researchers believe that the patient is not suitable to participate in this study. 19. Participated in other clinical trials.
Contact & Investigator
YiLong Wang
PRINCIPAL INVESTIGATOR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT06759753 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06759753 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06759753 currently recruiting?
Yes, NCT06759753 is actively recruiting participants. Contact the research team at yilong528@gmail.com for enrollment information.
Where is the NCT06759753 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06759753 clinical trial?
NCT06759753 is sponsored by Beijing Tiantan Hospital. The principal investigator is YiLong Wang at Beijing Tiantan Hospital. The trial plans to enroll 192 participants.
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