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

NCT03413202 | Completed Phase 4 DMC

• 1 other identifier: EBCAS
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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 purpose of this study is to determine whether butylphthalide can improve dynamic Cerebral Autoregulation (dCA) in large-artery atherosclerosis acute ischemic stroke.

Conditions

Acute Ischemic Stroke

Keywords

butylphthalide(NBP); large-artery atherosclerosis acute ischemic stroke; dynamic Cerebral Autoregulation(dCA)

Outcome Measures

Primary Outcomes (1)

• Phase difference (PD) in degree

  A dCA parameter derived from transfer function analysis.

  within 14 days injection NBP,and 90 days of sequential therapy

Study Arms (2)

butylphthalide(NBP)

EXPERIMENTAL

Based on the standard medical care, 25mg of NBP injection, and 100ml of 0.9% saline; NBP capsule

Drug: butylphthalide(NBP)

placebo

PLACEBO COMPARATOR

Based on the standard medical care, 100ml of 0.9% saline as the placebo; starch capsule as the placebo

Drug: placebo

Interventions

butylphthalide(NBP) DRUG

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.

butylphthalide(NBP)

placebo DRUG

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.

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Related Publications (1)

• Guo ZN, Yue BH, Fan L, Liu J, Zhu Y, Zhao Y, Zhong J, Lou Z, Liu XL, Abuduxukuer R, Zhang P, Qu Y, Shen Z, Shi B, Zhang KJ, Liu J, Chang J, Jin H, Sun X, Yang Y. Effectiveness of butylphthalide on cerebral autoregulation in ischemic stroke patients with large artery atherosclerosis (EBCAS study): A randomized, controlled, multicenter trial. J Cereb Blood Flow Metab. 2023 Oct;43(10):1702-1712. doi: 10.1177/0271678X231168507. Epub 2023 Apr 6.

  PMID: 37021629 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

3-n-butylphthalide

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yi Yang, MD, PhD

  Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of First Hospital of Jilin University

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 29, 2018
• Study Start: February 28, 2018
• Primary Completion: March 25, 2022
• Study Completion: May 25, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

CN (1)