Clinical trial NCT05757635: A Research of Application of the New Model of Standardized Secondary Prevention of Stroke
Official title: A Research of Application of the New Model of Standardized Secondary Prevention of Stroke
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Ischemic Stroke
Keywords: ischemic stroke
standard secondary prevention
artificial intelligence technology
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: CSPC-NBP Pharmaceutical Co., Ltd.
First posted: 2023-03-07
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke

Brief summary: To promote the application of the standardized secondary prevention of stroke in primary hospitals,and further reduce the recurrence rate, disability rate, and socioeconomic burden in China, the investigators aim to popularize the standard secondary stroke prevention strategy through artificial intelligence technology, and thus to establish an information management system for standard treatment of stroke.

Detailed description: Ischemic stroke is characterized by high incidence, high recurrence rate, high mortality rate and high disability rate. During the Tenth Five-Year Plan period, standardized treatment of acute ischemic stroke has been demonstrated to reduce mortality in acute phase. With the rapid economic development and dramatic changes in lifestyle in China, the prevalence of stroke has been increasing significantly and has become a serious public health threat. The global stroke report released by the New England Journal of Medicine in 2018 showed that China has the highest incidence of stroke and burden of stroke related diseases. The national cause of death survey also indicated that stroke is the highest cause of death among urban residents and the second highest among rural residents in China. About 3/4 of stroke patients suffered variable degrees of disability, and the recurrence rate within 1 year after stroke is up to 17.7%, which is much higher than that in the developed countries. Moreover, post-stroke disability brings a heavy burden of economy and human care to the society and family. Stroke prevention is consequently of great importance. Findings from previous studies have repeatedly verified the effectiveness of standard stroke secondary prevention strategies. However, there is a disconnect between stroke prevention and treatment guidelines, and clinical practice, leading to an insufficient application of standard stroke secondary prevention. An improvement of the adherence to secondary ischemic stroke prevention in China has already been demonstrated by the implementation of a guideline-based, structured care program, which has been promoted to more than 150 hospitals and effectively improved stroke prevention and treatment in China. To improve the application of secondary prevention system in primary hospitals, and further reduce the recurrence and disability rate of stroke, and socioeconomic burden in China, the investigators aim to popularize the standard stroke secondary prevention through artificial intelligence technology, thus to establish an economically efficient information management platform for stroke secondary prevention.

Eligibility criteria: Inclusion Criteria:

1. First clinical onset or previous cerebral infarction without serious sequela (mRS is 0-2 points)
2. Age ≥ 18 years old
3. Patients or family members own and use smart phones
4. Informed consent signed by the patient or his/her legal representative

Exclusion Criteria:

1. Cranial CT confirmed intracranial hemorrhagic diseases (cerebral hemorrhage, subarachnoid hemorrhage) or malignant space occupying lesions
2. Transient ischemic attack, or stroke mimic
3. Cerebral embolism or suspected cerebral embolism, or other clear anticoagulant indications (such as DVT)
4. Severe disturbance of consciousness: GCS≤8
5. Dysphagia; or gastrointestinal disease or gastrointestinal surgery may affect gastrointestinal absorption
6. After the onset of thrombolysis, stent surgery, or will carry out arteriovenous thrombolysis, interventional or stent surgery patients
7. Angioplasty or other operations that need to suspend antiplatelet drugs may be performed in the last 3 months
8. Patients with severe heart, lung and kidney dysfunction (creatinine \> 2.0 mg/dL or 177 /μ mol/L), severe liver damage (alanine aminotransferase/aspartate transaminas，ALT/AST\>1.5×ULN), malignant tumor, etc., with life expectancy less than 3 months
9. Patients with hemorrhagic tendency, laboratory examination: international normalized ratio （INR）\> 1.5 or activated partial thromboplastin time（APTT） \> 2 times or platelet （PLT ）\< 100×10\^9 / L
10. Patients with previous allergy or intolerance to clopidogrel and aspirin
11. Pregnant or lactating women
12. Patients who could not be followed up as required during the study period
13. Without pariticipation in other intervention clinical studies in the last three months

Primary outcomes:
measure: The recurrence rate of acute ischemic stroke
timeFrame: 3 months
Secondary outcomes:
measure: The improvement of National Institutes of Health Stroke Scale（NIHSS） score
timeFrame: 3 months
measure: The improvement of Modified Rankin Scale（mRS）score
timeFrame: 3 months，6 months ，12 months
measure: The improvement of Barthel index score
timeFrame: 3 months，6 months ，12 months
measure: The ratio of good prognosis
timeFrame: 3 months，12 months
measure: The recurrence rate of acute ischemic stroke
timeFrame: 12 months
measure: The composite endpoint event
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
measure: Medication compliance
timeFrame: 12 months
measure: Standard reaching rate of risk factors
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: