The study is designed as a multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy and safety of TTYP01 tablets in the treatment of acute ischemic stroke.
A multicenter, randomized, double-blind, parallel, placebo-controlled trial design is used to evaluate the efficacy and safety of TTYP01 tablets in the treatment of patients with acute ischemic stroke. It is estimated that 618 patients will be enrolled and randomly assigned to the treatment group and the placebo control group in a 1:1 ratio, with 309 patients in each group. Normally, the duration of this study is approximately 90 days. This study will be divided into 2 periods, with a total of five visits: Treatment observation period: D1 \~ D28 (the minimum length of in-hospital observation will be not less than 7 days), including 3 visits (V1- V3); follow-up period: D29 \~ D90, including 2 visits (V4: D60 ± 5 for telephone follow-up; V5: D90 ± 5, returning to hospital for end-of-study visit).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
614
Administered 30\~60 minutes before breakfast and dinner (i.e., fasting state), bid. Subjects are given 2 tablets (60 mg) of investigational drug each time. The first administration should be administered within 1 hour after enrollment. If the subject is randomized in a fed state, the first administration may be administered in a non-fasting state. The interval between the first and second administration should be at least 6 hours, with continuous administration for 28 days (56 administrations).
Administered 30\~60 minutes before breakfast and dinner (i.e., fasting state), bid. Subjects are given 2 tablets (0 mg) of placebo each time. The first administration should be administered within 1 hour after enrollment. If the subject is randomized in a fed state, the first administration may be administered in a non-fasting state. The interval between the first and second administration should be at least 6 hours, with continuous administration for 28 days (56 administrations).
Daping Hospital
Chongqing, Chongqing Municipality, China
Proportion of subjects with mRS score ≤1 on Day 90 of treatment.
The mRS (modified Rankin Scale) is a scoring system used to assess the ability of post-stroke patients in their daily lives. It assesses the degree of functional impairment of patients after stroke through a standardized questionnaire, and is one of the most widely used tools for assessing the sequelae of stroke internationally. The MRS scores range from 0 to 5, with higher scores indicating more severe disability in patients.
Time frame: 90 days after treatment initiation
mRS score on Day 90 of treatment
The mRS (modified Rankin Scale) is a scoring system used to assess the ability of post-stroke patients in their daily lives. It assesses the degree of functional impairment of patients after stroke through a standardized questionnaire, and is one of the most widely used tools for assessing the sequelae of stroke internationally. The MRS scores range from 0 to 5, with higher scores indicating more severe disability in patients.
Time frame: 90 days after treatment initiation
Proportion of subjects with mRS score ≤2 on D90 of treatment
The mRS (modified Rankin Scale) is a scoring system used to assess the ability of post-stroke patients in their daily lives. It assesses the degree of functional impairment of patients after stroke through a standardized questionnaire, and is one of the most widely used tools for assessing the sequelae of stroke internationally. The MRS scores range from 0 to 5, with higher scores indicating more severe disability in patients.
Time frame: 90 days after treatment initiation
Change from baseline in mRS score on D7, D28, D60 and D90 of treatment
The mRS (modified Rankin Scale) is a scoring system used to assess the ability of post-stroke patients in their daily lives. It assesses the degree of functional impairment of patients after stroke through a standardized questionnaire, and is one of the most widely used tools for assessing the sequelae of stroke internationally. The MRS scores range from 0 to 5, with higher scores indicating more severe disability in patients.
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Time frame: Baseline and 7, 28, 60, 90 days after treatment initiation
Change in NIHSS score from baseline on D7, D28 and D90 of treatment
The NIHSS (National Institutes of Health Stroke Scale) is a standardized neurological examination tool used to assess neurological deficits in stroke patients. The scale consists of 15 tests and the total score is the sum of the individual scores ranges from 0 to 42, with lower scores indicating a better state of the patient.
Time frame: Baseline and 7, 28, 90 days after treatment initiation
Proportion of patients with NIHSS score improvement ≥ 4 points on D7, D28, and D90 of treatment
The NIHSS (National Institutes of Health Stroke Scale) is a standardized neurological examination tool used to assess neurological deficits in stroke patients. The scale consists of 15 tests and the total score is the sum of the individual scores ranges from 0 to 42, with lower scores indicating a better state of the patient.
Time frame: 7, 28 and 90 days after treatment initiation
Proportion of subjects with NIHSS score of 0-1 on D7, D28 and D90 of treatment
The NIHSS (National Institutes of Health Stroke Scale) is a standardized neurological examination tool used to assess neurological deficits in stroke patients. The scale consists of 15 tests and the total score is the sum of the individual scores ranges from 0 to 42, with lower scores indicating a better state of the patient.
Time frame: 7, 28 and 90 days after treatment initiation
Change in BI score from baseline on D7, D28 and D90 of treatment
The BI (Barthel Index) is used to assess the patient's ability to perform activities of daily living and can be used to evaluate the patient's functional recovery before and after treatment, and it is one of the most widely used and researched methods of basic assessment of activities of daily living in clinical practice, with credible results. It is mainly based on the patient's actual daily performance and is not judged by the ability the patient may have. The BI scores range from 0 to 100, with higher scores indicating a better state of the patient.
Time frame: Baseline and 7, 28, 90 days after treatment initiation
Proportion of subjects with BI score ≥ 95 points on D7, D28 and D90 of treatment
The BI (Barthel Index) is used to assess the patient's ability to perform activities of daily living and can be used to evaluate the patient's functional recovery before and after treatment, and it is one of the most widely used and researched methods of basic assessment of activities of daily living in clinical practice, with credible results. It is mainly based on the patient's actual daily performance and is not judged by the ability the patient may have. The BI scores range from 0 to 100, with higher scores indicating a better state of the patient.
Time frame: 7, 28 and 90 days after treatment initiation
MoCA score and comparison on D7, D28 and D90 of treatment
The MoCA (Montreal Cognitive Assessment) Scale is a rating tool used to provide rapid screening for cognitive dysfunction. It includes 11 screening items in 8 cognitive domains: attention and concentration, executive function, memory, language, visual structural skills, abstract thinking, calculation and orientation. The total score is 30, with ≥26 being normal; the lower the score, the more severe the cognitive impairment.
Time frame: 7, 28 and 90 days after treatment initiation
HDRS score and comparison on D7, D28 and D90 of treatment
The HDRS (Hamilton Depression Scale) was developed by Hamilton in 1960 and is the most commonly used scale for assessing depressive states in clinical settings. There are three versions of this scale: 17-item, 21-item and 24-item. The 21-item version was used for this Clinical Study, with a score range from 0 to 64. A score greater than 30 is severe depression, greater than 20 is moderate depression, and greater than 17 is mild depression.
Time frame: 7, 28 and 90 days after treatment initiation
Proportion of subjects with recurrent stroke within 90 days of treatment
Time frame: within 90 days of treatment
Changes in cranial MRI findings (infarct volume) relative to baseline
Infarct volume will report in mm\^3
Time frame: Baseline and 5, 28 days after treatment initiation
Changes in cranial MRI findings (infarct area) relative to baseline
Infarct area will report in mm\^2
Time frame: Baseline and 5, 28 days after treatment initiation