Trials / Completed
CompletedNCT05086874
Using Real-world Evidence to Analyze the Clinical Effects and Adverse Events of Butylphthalide in Stroke Patients
A Real-world Retrospective Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 81,292 (actual)
- Sponsor
- Xin Huang · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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 Edaravone. 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 Edaravone 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.
Conditions
- Stroke
- Cerebral Infarction
- Brain Infarction
- Brain Ischemia
- Nervous System Diseases
- Central Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | butylphthalide | Observational only and no predesigned interventions in this study |
Timeline
- Start date
- 2022-05-07
- Primary completion
- 2023-02-01
- Completion
- 2023-03-01
- First posted
- 2021-10-21
- Last updated
- 2024-04-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05086874. Inclusion in this directory is not an endorsement.