An observational study in Stroke, Cerebral Infarction and Brain Infarction, sponsored by Xin Huang. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Xin Huang · Observational
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 81,292 is above the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Xin Huang as lead sponsor.
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Doctors diagnosed with ischemic stroke patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A group of patients with ischemic stroke, treated with butylphthalide
Other: butylphthalide
A group of patients with ischemic stroke, treated with Edaravone
Observational only and no predesigned interventions in this study
Also known as: observational only ,no intervention
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
Time frame: 90days
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%
Time frame: 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.
Time frame: 90days
Plan to share: Undecided — Haven't decided yet
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Feb 2023, 8 months.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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