Acute Ischemic StrokePhase 2XY03-EANCT05515393
A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke
A Phase 2 study testing XY03-EA in people with Acute Ischemic Stroke, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- XY03-EA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2022to 30 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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) ；
- Patients with substance abuse or addiction in the past year(narcotic or drugs , for example) ；
- Those who had taken any clinical trial drug or participated in any drug or device clinical trial or participated in other medical research activities in 3 months before screening and were judged not fit to participate in this study by the investigator;
- Any other circumstances considered by the investigator might affect the informed consent of the subject or adherence to the study protocol, otherwise the participation of the subject in the study might affect the outcome or his or her own safety.
Trial locations and contacts
1 site in 1 country.
China1 site
Shijiazhuang Yiling Pharmaceutical Co.,Ltd
Shijiazhuang, Hebei, 050036
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled, Dose-exploration Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke
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.
Read the detailed description
The population is patient who with acute ischemic stroke within 48 hours of onset (including RT-PA intravenous thrombolytic therapy) . The patients were randomized based on being received rt-PA Intravenous thrombolysis or not. Patients who met the inclusion criteria for the protocol were stratified randomly and assigned in a 1:1:1 ratio to three groups: the XY03-EA 300mg, 600mg two-dose group, and the placebo group. The study was divided into 3 stages: screening stage, treatment stage and follow-up stage. The sample size was 420 patients.
Main outcome: 1.To evaluate the efficacy and safety of XY03-EA tablets in the treatment of acute ischemic stroke.
Secondary outcome:
- Explore the dose-response relationship of XY03-EA tablets in the treatment of acute ischemic stroke, and provide data support for later clinical study;
- Explore PK characteristics of XY03-EA and its metabolites in patients with acute ischemic stroke based on population PK analysis method.
- Conditions
- Acute Ischemic Stroke
- Being tested
- XY03-EA, XY03-EA Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XY03-EADrug
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 PlaceboDrug
XY03-EA Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: XY03-EA Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point at 14(discharge) , 30,60,90 days after administration;
Measured: 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;
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at the 30,60,days after administration;
Measured: 30 and 60 days
The change of NIHSS score from baseline at 14(discharge) , 30,60,90 days after administration;
The change of NIHSS score from baseline at 14(discharge) , 30,60,90 days after administration; The NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: 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;
the proportion of patients with NIHSS score ≤1 or decrease ≥4 at 30,60, and 90 days after administration;
Measured: 30,60, and 90days
The proportion of patients with a BI ≥95 points at 90 days after administration;
The proportion of patients with a BI ≥95 points at 90 days after administration;The BI Scale is a 10-item scale that assesses the ability of daily living. Each item is given 15,10,5 or 0 points depending on whether or not the patient needs help and the degree of help and the time . The total score is 0 to 100 points, the higher the score, the better the independence and self-rationality. According to the assessment results, the ability of daily activities was divided into 3 grades: good, moderate and poor, with a score of more than 60 being good, and basic daily life being self-care; less than or equal to 40 points for poor, most of daily life relying on family care.
Measured: 90 days
The change in MMSE score compared with baseline at 90 days after administration;
The change in MMSE score compared with baseline at 90 days after administration; Mini-mental state examination (MMSE) can comprehensively, accurately and rapidly reflect the intelligence status and the degree of cognitive impairment of the subjects. The scale includes the following 7 aspects: time orientation, place orientation, immediate memory, attention and numeracy, delayed memory, language, visuospatial. The total score of the scale ranged from 0 to 30. The test scores are closely related to the educational level.
Measured: 90 days
New vascular events The proportion of patients with new vascular events
The proportion of patients with new vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) within 90 days after administration.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start24 Sep 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515393
- Sponsor's protocol ID
- XY03AIS2001
- Acronym
- XY03-EA
- Status last verified
- Jun 2023
- First submitted
- 8 Aug 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled, Dose-exploration Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05515393
- Acronym / sponsor ID
- XY03-EA / XY03AIS2001
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 24 Sep 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The population is patient who with acute ischemic stroke within 48 hours of onset (including RT-PA intravenous thrombolytic therapy) . The patients were randomized based on being received rt-PA Intravenous thrombolysis or not. Patients who met the inclusion criteria for the protocol were stratified randomly and assigned in a 1:1:1 ratio to three groups: the XY03-EA 300mg, 600mg two-dose group, and the placebo group. The study was divided into 3 stages: screening stage, treatment stage and follow-up stage. The sample size was 420 patients.
Main outcome: 1.To evaluate the efficacy and safety of XY03-EA tablets in the treatment of acute ischemic stroke.
Secondary outcome:
- Explore the dose-response relationship of XY03-EA tablets in the treatment of acute ischemic stroke, and provide data support for later clinical study;
- Explore PK characteristics of XY03-EA and its metabolites in patients with acute ischemic stroke based on population PK analysis method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| XY03-EA Tablet (300mg group) | Experimental | Drug: XY03-EA, Drug: XY03-EA PlaceboXY03-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 |
| XY03-EA Tablet (600mg group) | Experimental | Drug: XY03-EAXY03-EA 150 mg/tablet, 4 tablets ,three times a day, For 90 days, continuous administration Other Name:high dose |
| XY03-EA Placebo Tablet | Placebo comparator | Drug: XY03-EA PlaceboXY03-EA Placebo Tablet 150 mg/tablet, 4 tablets,three times a day, For 90 days, continuous administration Other Name: placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XY03-EAThe 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. | Drug | XY03-EA Tablet (300mg group), XY03-EA Tablet (600mg group) |
| XY03-EA PlaceboXY03-EA Placebo | Drug | XY03-EA Placebo Tablet, XY03-EA Tablet (300mg group) |
Primary outcome
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at 90 days after administration.
Time frame: 90 days
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.
7 secondary outcomes
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point at 14(discharge) , 30,60,90 days after administration.
Time frame: 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;
Time frame: 30 and 60 days
The change of NIHSS score from baseline at 14(discharge) , 30,60,90 days after administration;
Time frame: 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;
Time frame: 30,60, and 90days
The proportion of patients with a BI ≥95 points at 90 days after administration;
Time frame: 90 days
The change in MMSE score compared with baseline at 90 days after administration;
Time frame: 90 days
New vascular events The proportion of patients with new vascular events
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XY03-EA in people with Acute Ischemic Stroke, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at 90 days after administration. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.