Effectiveness of Butylphthalide on Dynamic Cerebral Autoregulation in Patients With Acute Ischemic Stroke.

• Status: Recruiting
• Trial end date: 2022-12-25
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, triple-blind, placebo-controlled, multicenter clinical trial. investigators plan to enroll 774 eligible patients, which will be randomized into either the butylphthalide (NBP) or placebo group in a 2:1 ratio.The main purpose of this study is to determine whether butylphthalide can improve dynamic Cerebral Autoregulation (dCA) in large-artery atherosclerosis acute ischemic stroke.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yi Yang
• Treatments: 3-n-butylphthalide

Criteria

Inclusion Criteria:

• 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;

• 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 Criteria:

• 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 drugs which can promote cerebral collateral circulation; establishment;

• 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.