Using Real-world Evidence to Analyze the Clinical Effects and Adverse Events of Butylphthalide in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
This is a retrospective, multi-center, real-world study. The researchers plan to include 10,000 cases of ischemic stroke patients using butylphthalide and 10,000 cases of ischemic stroke patients using Urinary Kallidinogenase. The main purpose is to analyze the effectiveness and safety of butylphthalide and establish the drug risk assessment management plan.

Detailed Description
-----------------
Ischemic stroke is a type of syndrome in which blood supply to the brain is impaired due to various reasons, leading to local brain tissue ischemia, hypoxic necrosis, and corresponding neurological deficits. It has a high incidence, high morbidity and disability. Features of high recurrence rate. Butylphthalide can improve the damage of central nervous system in patients with acute ischemic stroke, and can promote the improvement of patients with neurological deficits. Regarding butylphthalide in the treatment of ischemic stroke, there is still a lack of big data research based on the efficacy and safety of the real world. Therefore, it is planned to include 10,000 patients who used butylphthalide or Urinary Kallidinogenase in five hospitals from 2019 to 2021, and record the basic information of the patients, medication status and related test results. The data was cleaned, sorted and analyzed to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke.

Official Title
-----------------
A Real-world Retrospective Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke

Conditions
-----------------
Stroke, Cerebral Infarction, Brain Infarction, Brain Ischemia, Nervous System Diseases, Central Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: butylphthalide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: From January 2019 to August 2021, clinicians diagnosed patients with ischemic stroke requiring hospitalization. Exclusion Criteria: Patients who are unable to obtain information such as medical advice, laboratory test results, etc.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed group<br>A group of patients with ischemic stroke, treated with butylphthalide | Other: butylphthalide<br>* Observational only and no predesigned interventions in this study<br>* Other names: observational only ,no intervention;|
| Non-exposed group<br>A group of patients with ischemic stroke, treated with Urinary Kallidinogenase | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events | The probability of unanticipated and adverse medical events after the patient receives medication, but it does not necessarily have a causal relationship with the treatment | 90days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS | NIH stroke scale (NIHSS) to assess the degree of neurological deficit in stroke patients. The score ranges from 0 to 42 points, the higher the score, the more severe the nerve damage. Patients with a baseline assessment of> 16 points are likely to die, while those with a score of <6 are likely to recover well; for each additional point, the probability of a good prognosis is reduced by 17% | 90days | 
| mRS | Modified Rankin scale (mRS) is an indicator of the efficacy of functional disability. The score ranges from 0 to 5 points, and the clinical score will be increased to 6 points to indicate death. The higher the score, the more disability the patient is. | 90days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
butylphthalide, Ischemic Strokes, Real world research