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NCT Number: NCT05086874

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

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.

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Key information

Conditions

Stroke Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Infarction Cerebrovascular Disorders Infarction Ischemia Ischemic Stroke Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong Provincial, 250014, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

butylphthalide

Other

Observational only and no predesigned interventions in this study

Other names: observational only ,no intervention

Primary outcomes

  1. The incidence of adverse events

    Time frame: 90days

    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

Secondary outcomes

  1. NIHSS

    Time frame: 90days

    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%

  2. mRS

    Time frame: 90days

    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.

Sponsors and collaborators

Lead sponsor

Xin Huang

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2021
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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