Status:
COMPLETED
Effectiveness of Butylphthalide on Dynamic Cerebral Autoregulation in Patients With Acute Ischemic Stroke.
Lead Sponsor:
Yi Yang
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This is a randomized, triple-blind, placebo-controlled, multicenter clinical trial. Eligible patients will be randomized into either the butylphthalide (NBP) or placebo group in a 2:1 ratio.The main p...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- Age ranging from 18 to 80, both genders;
- Within 48 hours symptoms onset;
- According to TOAST classification, diagnosed to be large-artery atherosclerosis ischemic stroke, without history of stroke in the past three months;
- 5≤National Institutes of Health Stroke Scale (NIHSS) ≤25;
- Unilateral internal carotid artery (ICA) or M1 segment of middle cerebral artery (MCA) stenosis (rate of stenosis ranging from 50-99%);
- Sufficient bilateral temporal bone windows for insonation of the middle cerebral artery;
- Glasgow Coma Scale (GCS) ≥ 8;
- Willing to participate and sign the informed consent.
Exclusion
- Patients who have received or plan to undergo intravascular interventional treatment/thrombolytic therapy;
- Coma or agitation, and can't cooperate to complete dCA;
- Has been given butylphthalide injection or capsules;
- Arrhythmia, anemia and hyperthyroidism which may influence the stability of cerebral blood flow diagnosed by two physicians by electrocardiogram and laboratory tests;
- Other intracranial diseases, including cerebral hemorrhage (primary or secondary), intracranial neoplasm, aneurysm, arteriovenous malformation, etc;
- Alanine transaminase (ALT) or glutamic-oxalacetic transaminase (AST) continued to rise more than 3 times the upper limit of normal , creatinine clearance rate\<30ml/min;
- Pre-stroke Modified Rankin Scale (mRS) score ≥ 2;
- Malignant neoplasm and expected lifetime \< 2 years;
- Pregnant and lactating women;
- Participating in other trials or has been participated in other trials in recent 3 months;
- Dementia and mental illness.
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2022
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT03413202
Start Date
February 28 2018
End Date
May 25 2022
Last Update
June 30 2022
Active Locations (1)
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1
First Hospital of Jilin University
Changchun, Jilin, China, 130000