Effectiveness of Butylphthalide on Dynamic Cerebral Autoregulation in Patients With Acute Ischemic Stroke. (EBCAS)
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|ClinicalTrials.gov Identifier: NCT03413202|
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : July 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke||Drug: butylphthalide(NBP) Drug: placebo||Phase 4|
Cerebral stroke, the first cause of death in China, seriously affects the health and living of people.Its high incidence, disability, mortality and recurrence rate give a heavy burden on the family, society and country. According to TOAST classification, large-artery atherosclerosis ischemic stroke is one of the most common subtypes, and majority experts demonstrate its dynamic Cerebral Autoregulation (dCA) is impaired in affected hemisphere.
Thrombolytic therapy with intravenous tissue plasminogen activator (tPA), which remains the only therapeutic drug for acute ischemic stroke approved by the US Food and Drug Administration, is limited by the narrow time window of thrombolysis, bleeding complications, or high costs. Other treatment strategies mainly utilize therapeutic agents to prevent or reduce cell damage from ischemia. Butylphthalide (NBP) is a multiple target drug for the treatment of acute mild to moderate ischemic cerebral stroke.
Cerebral autoregulation (CA) is the main mechanism that maintains relatively constant cerebral blood flow, which is critical for the normal functioning of physiological functions, as well as the occurrence, development and prognosis of the cerebral stroke.whether NBP can improve the dCA in large-artery atherosclerosis acute ischemic stroke has not been illustrated.
Thus, in this study, investigators plan to enroll 774 eligible patients, which will be randomized into either the NBP or placebo group in a 2:1 ratio within 90 days follow-up to explore whether NBP can improve the dCA in large-artery atherosclerosis acute ischemic stroke. DCA measurement will be performed at 0, 10-14 and 83-97 days after entering the trial, nurses will collect intravenous blood 6ml 3 times (each time before dCA measurement, the blood samples will be stored for laboratory test). High resolution nuclear magnetic resonance will conduct twice (0, 83-97days after entering the trial). Clinical information, neuroimaging data, biochemical examinations and follow-up information will be collected and recorded in case report form (CRF) once signing of informed consent.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effectiveness of Butylphthalide on Dynamic Cerebral Autoregulation in Patients With Large-artery Atherosclerosis Acute Ischemic Stroke(EBCAS)|
|Actual Study Start Date :||February 28, 2018|
|Estimated Primary Completion Date :||November 25, 2020|
|Estimated Study Completion Date :||February 2021|
Based on the standard medical care, 25mg of NBP injection, and 100ml of 0.9% saline; NBP capsule
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2014), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.In addition, 25mg butylphthalide(NBP) injection, and 100ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, infusion for 14 days, then, butylphthalide(NBP) capsule for 76 days.
Placebo Comparator: placebo
Based on the standard medical care, 100ml of 0.9% saline as the placebo; starch capsule as the placebo
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2014), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.In addition, 100ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, infusion for 14 days, then, starch capsule for 76 days.
- Phase difference (PD) in degree [ Time Frame: within 14 days injection NBP,and 90 days of sequential therapy ]A dCA parameter derived from transfer function analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413202
|Contact: Yi Yang, MD, PhDfirstname.lastname@example.org|
|Contact: Zhenni Guo, MDemail@example.com|
|First Hospital of Jilin University||Recruiting|
|Changchun, Jilin, China, 130000|
|Contact: Yi Yang, MD, PhD firstname.lastname@example.org|
|Study Chair:||Yi Yang, MD, PhD||Neuroscience Center, Department of Neurology, The First Hospital of Jilin University|