A Research of Application of the New Model of Standardized Secondary Prevention of Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

A Research of Application of the New Model of Standardized Secondary Prevention of Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05757635
• Other study ID #: Archimedes
• Status: Not yet recruiting
• Start date: March 20, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	CSPC-NBP Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recurrence rate of acute ischemic stroke	The recurrence rate of acute ischemic stroke	3 months
Secondary	The improvement of National Institutes of Health Stroke Scale(NIHSS) score	The national institutes of health stroke scale score range is 0-42 points. The higher the score, the more serious the nerve defect.	3 months
Secondary	The improvement of Modified Rankin Scale(mRS)score	The improvement of modified Rankin Scale score is divided into 6 levels, from 0 to 5. Level 0 is the best state, and level 6 is the death state	3 months,6 months ,12 months
Secondary	The improvement of Barthel index score	The Barthel index is 0 to 100 points. The closer the score is to 100 points, the stronger the self-care ability of the patient, while the lower the score, the worse the self-care ability of the patient.	3 months,6 months ,12 months
Secondary	The ratio of good prognosis	The proportion of patients with good prognosis of neurological function (mRS < 2)	3 months,12 months
Secondary	The recurrence rate of acute ischemic stroke	The recurrence rate of acute ischemic stroke	12 months
Secondary	The composite endpoint event	? New vascular focal neurologic deficit lasting for more than 24 hours revealed the presence of a new cerebral infarction, or a new angiogenic focal neurological deficit. Cranial imaging confirmed non traumatic cerebral parenchymal hemorrhage or new subarachnoid hemorrhage; ? Death of all causes: including death of any known or unknown cause. The causes of death were classified as follows: ischemic stroke, hemorrhagic stroke, cardiogenic death, hemorrhage (excluding intracranial hemorrhage), infection, malignant tumor, trauma, death due to other vascular causes (including pulmonary embolism), death due to other non vascular causes, and unclear causes	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
Secondary	Medication compliance	Medication compliance	12 months
Secondary	Standard reaching rate of risk factors	Standard reaching rate of common stroke risk factors, including hypertension, diabetes, hyperlipidemia, smoking and alcohol.	12 months