Acute Ischemic StrokeNCT05757635
A Research of Application of the New Model of Standardized Secondary Prevention of Stroke
An observational study of Acute Ischemic Stroke, run by Peking Union Medical College Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2023to 31 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke
Who may be able to join
- First clinical onset or previous cerebral infarction without serious sequela (mRS is 0-2 points)
- Age ≥ 18 years old
- Patients or family members own and use smart phones
- Informed consent signed by the patient or his/her legal representative
Who cannot join
- Cranial CT confirmed intracranial hemorrhagic diseases (cerebral hemorrhage, subarachnoid hemorrhage) or malignant space occupying lesions
- Transient ischemic attack, or stroke mimic
- Cerebral embolism or suspected cerebral embolism, or other clear anticoagulant indications (such as DVT)
- Severe disturbance of consciousness: GCS≤8
- Dysphagia; or gastrointestinal disease or gastrointestinal surgery may affect gastrointestinal absorption
- After the onset of thrombolysis, stent surgery, or will carry out arteriovenous thrombolysis, interventional or stent surgery patients
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- Angioplasty or other operations that need to suspend antiplatelet drugs may be performed in the last 3 months
- 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
- 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
- Patients with previous allergy or intolerance to clopidogrel and aspirin
- Pregnant or lactating women
- Patients who could not be followed up as required during the study period
- Without pariticipation in other intervention clinical studies in the last three months
About this study
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Keywords
- ischemic stroke, standard secondary prevention, artificial intelligence technology
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate of acute ischemic stroke
The recurrence rate of acute ischemic stroke
Measured: 3 months
Secondary outcomes (8)
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.
Measured: 3 months
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
Measured: 3 months，6 months ，12 months
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.
Measured: 3 months，6 months ，12 months
The ratio of good prognosis
The proportion of patients with good prognosis of neurological function (mRS < 2)
Measured: 3 months，12 months
The recurrence rate of acute ischemic stroke
The recurrence rate of acute ischemic stroke
Measured: 12 months
The composite endpoint event
① 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
② 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
Measured: 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
Medication compliance
Medication compliance
Measured: 12 months
Standard reaching rate of risk factors
Standard reaching rate of common stroke risk factors, including hypertension, diabetes, hyperlipidemia, smoking and alcohol.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start20 Mar 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC-NBP Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757635
- Sponsor's protocol ID
- Archimedes
- Status last verified
- Dec 2022
- First submitted
- 8 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research of Application of the New Model of Standardized Secondary Prevention of Stroke
- ClinicalTrials.gov ID
- NCT05757635
- Acronym / sponsor ID
- Archimedes
- Conditions
- Acute Ischemic Stroke
- Keywords
- ischemic stroke, standard secondary prevention, artificial intelligence technology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- CSPC-NBP Pharmaceutical Co., Ltd.
- Study start
- 20 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Mar 2023 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke
Key inclusion criteria (4 listed)
- First clinical onset or previous cerebral infarction without serious sequela (mRS is 0-2 points)
- Age ≥ 18 years old
- Patients or family members own and use smart phones
- Informed consent signed by the patient or his/her legal representative
Key exclusion criteria (13 listed)
- Cranial CT confirmed intracranial hemorrhagic diseases (cerebral hemorrhage, subarachnoid hemorrhage) or malignant space occupying lesions
- Transient ischemic attack, or stroke mimic
- Cerebral embolism or suspected cerebral embolism, or other clear anticoagulant indications (such as DVT)
- Severe disturbance of consciousness: GCS≤8
- Dysphagia; or gastrointestinal disease or gastrointestinal surgery may affect gastrointestinal absorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The recurrence rate of acute ischemic stroke
Time frame: 3 months
The recurrence rate of acute ischemic stroke
8 secondary outcomes
The improvement of National Institutes of Health Stroke Scale（NIHSS） score
Time frame: 3 months
The improvement of Modified Rankin Scale（mRS）score
Time frame: 3 months，6 months ，12 months
The improvement of Barthel index score
Time frame: 3 months，6 months ，12 months
The ratio of good prognosis
Time frame: 3 months，12 months
The recurrence rate of acute ischemic stroke
Time frame: 12 months
The composite endpoint event
Time frame: 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
Medication compliance
Time frame: 12 months
Standard reaching rate of risk factors
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Peking Union Medical College Hospital.
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 4 inclusion and 13 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 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 recurrence rate of acute ischemic stroke (time frame: 3 months). 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 7 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.