Aleeto in Acute ISchemic Stroke：A RandomISed Controlled Clinical Trial

NCT06759753 | Recruiting Phase 2 DMC

• 1 other identifier: HX-A-2024088
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

Aleeto; Placebo parallel-controlled; Double Blind Study; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change from baseline in NIH Stroke Scale

  NIH Stroke Scale (NIHSS) scores from 0 to 42. A higher score indicates worse neural function.

  At 14 days after randomization

Secondary Outcomes (10)

• Change from baseline in NIH Stroke Scale

  At 7±1 days after randomization.

• Change from baseline in Modified Rankin Scale

  At 90±7days after randomization

• Change from baseline in Fugl-Meyer Assessment

  At 14±2 and 90±7days after randomization.

• Change from baseline in Ashworth scale

  At 14±2 and 90±7days after randomization.

• The ratio of modified Barthel index ≥95 points

  At 90±7days after randomization.

Other Outcomes (5)

• Imaging markers of brain tissue edema

  At 14±2 days post-randomization or before discharge

• Neurocellular metabolic markers

  At 14±2 days post-randomization or before discharge

• Hypersensitivity events

  From randomization to the end of treatment at 90±7days weeks

Study Arms (3)

Experimental group 1

EXPERIMENTAL

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.

Drug: Aleeto

Experimental group 2

EXPERIMENTAL

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.

Drug: Aleeto

Placebo group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Aleeto DRUG

According to the groups, patients would be treated with Aleeto via intravenous injection, and the specific dosage of Aleeto will depend on the grouping.

Experimental group 1; Experimental group 2

Placebo DRUG

Placebo with the same dosage form, odor and color as Aleeto was administered in the same way and course of treatment.

Placebo group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).
• 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).
• Resistant Hypertension, systolic pressure ≥220mmHg or diastolic pressure ≥120mmHg.
• 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).
• Body Mass Index (BMI) \< 16kg/m2 or BMI\> 35kg/m2.
• Severe organic diseases with expected survival time \<5 years, such as malignant tumor.
• 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.
• Combined with alcohol and drug abuse history.
• 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.
• Received any vaccinations within the past 28 days.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• YiLong Wang

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YiLong Wang

CONTACT

59975885; yilong528@gmail.com

WeiQi Chen

CONTACT

weiqichen@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice President of Beijing Tiantan Hospital

Model Details: This trial is a prospective, double-blind, 1:1:1 randomized controlled study. 192 patients will be randomly assigned to 3 groups. Two dose groups are set 130μg/day and 260μg/day and one placebo group.

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: March 21, 2025
• Primary Completion: November 30, 2025
• Study Completion: January 31, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)