A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke

NCT05515393 | Unknown Phase 2 DMC

• 1 other identifier: XY03AIS2001
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

Overall Design: a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-exploration study. Main outcome: 1.To evaluate the efficacy and safety of XY03-EA tablets in the treatment of acute ischemic stroke.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at 90 days after administration.

  The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at 90 days after administration. Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead. The mRS scores between 3 to 6 points are considered to be poor functional outcome.

  90 days

Secondary Outcomes (7)

• The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point at 14(discharge) , 30,60,90 days after administration.

  14(discharge) , 30,60,90 days

• The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at the 30,60,days after administration;

  30 and 60 days

• The change of NIHSS score from baseline at 14(discharge) , 30,60,90 days after administration;

  14(discharge) , 30,60,90 days

• The proportion of patients with NIHSS score ≤1 or decrease ≥4 at 30,60, and 90 days after administration;

  30,60, and 90days

• The proportion of patients with a BI ≥95 points at 90 days after administration;

  90 days

Study Arms (3)

XY03-EA Tablet (300mg group)

EXPERIMENTAL

XY03-EA 150 mg/tablet, 2 tablets，three times a day； XY03-EA Placebo 150 mg/tablet, 2 tablets，three times a day； For 90 days, continuous administration Other Name: low dose

Drug: XY03-EA; Drug: XY03-EA Placebo

XY03-EA Tablet (600mg group)

EXPERIMENTAL

XY03-EA 150 mg/tablet, 4 tablets ,three times a day, For 90 days, continuous administration Other Name:high dose

Drug: XY03-EA

XY03-EA Placebo Tablet

PLACEBO COMPARATOR

XY03-EA Placebo Tablet 150 mg/tablet, 4 tablets,three times a day, For 90 days, continuous administration Other Name: placebo

Drug: XY03-EA Placebo

Interventions

XY03-EA DRUG

The sample size was 420 patients, and 140 patients were treated with XY03-EA 300 mg, 600 mg and placebo respectively. The 300-mg group took two tablets of placebo and two tablets of XY03-EA once, three times a day. The 600-mg group took four tablets of XY03-EA once, three times a day. The placebo group took four tablets of placebo once ,three times a day.

XY03-EA Tablet (300mg group); XY03-EA Tablet (600mg group)

XY03-EA Placebo DRUG

XY03-EA Placebo

XY03-EA Placebo Tablet; XY03-EA Tablet (300mg group)

Eligibility Criteria

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

You may qualify if:

• Age 18-80 years old (including 18 and 80 years old) ；
• The patients who diagnosed as acute ischemic stroke according to the Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018, total or partial anterior circulation infarction according to the Oxfordshire community stroke classification (OCSP) ;
• For the patients who received standard intravenous thrombolytic therapy, only the patients who received rt-PA standard intravenous thrombolytic therapy within 4.5 hours of onset were enrolled；
• Before randomization, 6 points ≤ NIHSS score ≤20 points;
• From"The last time it seemed normal" to ≤48 hours after the beginning of the study , for the patients who had stroke after waking up or because of aphasia, disturbance of consciousness and other reasons can not accurately time the appearance of symptoms, the time of onset should take the last time the patient showed normally as standard;
• The patients who first attacked, or the patients who relapsed had a good prognosis after the last attacked , their mRS score was ≤1 before the onset of the disease.
• Understand and follow the procedure of the study, the patient or guardian agrees to participate, and sign the informed consent form.

You may not qualify if:

• Imaging confirmed intracranial hemorrhagic diseases: hemorrhagic stroke, transformation of symptomatic hemorrhage, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, intraventricular hemorrhage, traumatic intracerebral hemorrhage, etc.
• The patients who received urokinase thrombolysis after the onset of the disease were prepared to undergo or had undergone intravascular interventional therapy;
• Severe disturbance of consciousness:People with consciousness disorder can be defined as "NIHSS score Ia ≥2 points"；
• Neuroprotective drugs, including Edaravone, Edaravone dexborneol , Butylphthalide, Piracetam and Citicoline, were used after the onset of the disease；
• Renal insufficiency: serum creatinine \> 1.2 times the upper limit of normal, or other known severe renal insufficiency;
• Liver function damage: AST or ALT \> 1.5 times the upper limit of normal value, or other known liver diseases such as acute and chronic hepatitis, cirrhosis, etc.
• Patients with poor blood pressure control after active treatment: systolic blood pressure ≥220mmHg and/or diastolic blood pressure ≥120mmHg; hypotension: systolic blood pressure ≤80mmHg and/or diastolic blood pressure ≤40mmhg;
• Severe hyperglycaemia/hypoglycaemia: blood glucose ≥400 mg/dl (22.2 mmol/l) or ≤50 mg/dl (2.8 mmol/L) ;
• Heart rate less than 50 beats/min and/or heart rate greater than 120 beats/min; Second to third degree atrioventricular block; Patients with previous heart failure (NYHA Class III or IV) , unstable angina, acute myocardial infarction, and severe arrhythmia within 6 months;
• Patients with dementia, severe Parkinson's disease, mental disorders, claudication, osteoarthropathy, and other disorders that may affect the outcome of treatment；
• Patients with malignancy, hematologic, digestive, or other serious diseases of the system, or the diseases with bleeding tendency (hemophilia, for example) ；
• Expected survival time ≤3 months;
• Patients with a history of severe food or drug allergies, or known allergies to butylphthalide, or celery;
• Pregnant and lactating or planning pregnancy;
• Those who had met the criteria for heavy drinking within 3 months before the screening period, that is, daily drinking ≥5 standard drinking quantity (1 standard drinking quantity is equal to 120 ml (2.5 units) of wine, 360 ml (1 can) of beer or 45 ml (1 unit) of liquor) ；

Sponsors & Collaborators

• Shijiazhuang Yiling Pharmaceutical Co. Ltd: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Shijiazhuang Yiling Pharmaceutical Co.,Ltd

Shijiazhuang, Hebei, 050036, China

Location

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 25, 2022
• Study Start: September 24, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)