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Taking people in ChinaPhase 2

Tests Aleeto against placebo in acute ischemic stroke

Tests Aleeto or placebo in adults with moderate to severe acute ischemic stroke.

Key facts

Who runs it
Beijing Tiantan Hospital
Where
Beijing, ChinaSee the site
Trial code
Registry title
Aleeto in Acute ISchemic Stroke:A RandomISed Controlled Clinical Trial
Status
Recruiting
Phase
Phase 2
People taking part
192 people, planned
Started
21 Mar 2025
Planned end
31 Jan 2026
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Aleeto
  • Placebo
Record updated
3 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 30 to 80 with a moderate to severe acute stroke caused by a blocked blood vessel in the brain, within 72 hours of the first symptoms.

Age
30 to 80 years.
Sex
All sexes can join.
Disease stage
Acute ischemic stroke confirmed by CT or MRI, with symptoms starting 72 hours ago or less. NIHSS score between 6 and 24, with a score of 1 or more on items 5 and 6.
Earlier treatment
Not stated. Before the stroke, the person had to be independent in daily life (mRS below 2). No other investigational drug within 30 days or 5 drug half-lives, and no vaccination in the past 28 days.

Main reasons for not taking part

  • Bleeding in the brain seen on head CT
  • Severe kidney or liver problems, or severe heart failure
  • HIV, hepatitis C or hepatitis B infection
  • Women who can have children, are pregnant or are breastfeeding
  • Major surgery, spinal or brain surgery, or severe injury in the past 4 weeks

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • Age between 30 and 80 years (30 ≤ age ≤ 80)
  • Diagnosis of acute ischemic stroke confirmed by CT or MRI, according to the "Key Points for Diagnosis of Major Cerebrovascular Diseases in China 2019."
  • Time from symptom onset ≤ 72 hours
  • NIHSS score between 6 and 24, with a score of ≥ 1 on items 5 and 6 of the NIHSS
  • Pre-stroke mRS (modified Rankin Scale) < 2, indicating independent activities of daily living
  • Signed informed consent

Who cannot take part

  • Combined with alcohol and drug abuse history
  • Received any vaccinations within the past 28 days
  • Use of other investigational drugs within 30 days or 5 drug half-lives
  • Intracranial hemorrhagic diseases identified by head CT: cerebral hemorrhage, extradural hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc
  • Combined with other active and major neurological diseases (such as induced seizures, poor drug control of recurrent seizures, multiple sclerosis, intracranial tumors, etc.)
  • Resistant Hypertension, systolic pressure ≥220mmHg or diastolic pressure ≥120mmHg
  • Known history of allergy to biological agents such as proteins and cell products
  • History of intracranial or spinal surgery, major surgery, or severe physical trauma within the past 4 weeks
  • 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)
  • 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)
  • 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
  • History of severe anemia within the past 1 month (hemoglobin < 90g/L)
  • Severe organic diseases with expected survival time <5 years, such as malignant tumor
  • Body Mass Index (BMI) < 16kg/m2 or BMI> 35kg/m2
  • Women of child bearing potential, pregnant or breastfeeding
  • 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
  • Unable to complete follow-up due to geographical or other reasons
  • The researchers believe that the patient is not suitable to participate in this study
  • Participated in other clinical trials

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 30 and 80 years old?

Where in China

  • Beijing Tiantan HospitalBeijing, ChinaContact: Yilong WangTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Experimental group 1Treatment being tested

    Intravenous administration of Aleeto at 130μg/day for 14±2 days (130μg Aleeto with 100 ml sodium chloride injection), along with Ginkgo Ester Dropping Pills, 4 pills per dose, 3 times/day, orally, for 90 days.

    Treatment: Aleeto

  • Experimental group 2Treatment being tested

    Intravenous administration of Aleeto at 130μg/day for 14±2 days (260μg Aleeto with 100 ml sodium chloride injection), along with Ginkgo Ester Dropping Pills, 4 pills per dose, 3 times/day, orally, for 90 days.

    Treatment: Aleeto

  • Placebo groupPlacebo, for comparison

    Placebo with the same dosage form, odor and color as Aleeto was administered in the same way and course of treatment, along with Ginkgo Ester Dropping Pills, 4 pills per dose, 3 times/day, orally, for 90 days.

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Aleeto in Acute ISchemic Stroke:A RandomISed Controlled Clinical Trial
Plain-language title
Tests Aleeto against placebo in acute ischemic strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06759753, who can take part
Record updated
3 September 2025