The Impact of NBP on the Collateral Circulation in ICA/M1 Occlusion

NCT ID: NCT02594995

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2019-12-30

Brief Summary

Stroke is the first leading cause of death in China, and is responsible for almost 22.4% of deaths. In approximately 80% of cases stroke is ischaemic, i.e. caused by disruption of blood flow to part of the brain from an acute arterial occlusion. Survival of penumbral tissue distal to an arterial occlusion depends on collateral circulation via the Circle of Willis and leptomeningeal anastomises. Collateral flow is dynamic and failure is associated with infarct growth. The presence of adequate collaterals has been shown to be associated with age, history of statin use, and non-hypertension. Dl-3-n-butylphthalide (NBP), isolated from the seeds of celery, and found to exert protective effects against ischemic brain and increase leptomeningeal blood flow. This study investigate whether NBP injection prescribed during acute stroke will have a significant effect to improve collateral circulation in patients of anterior circulation occlusion.

Conditions

Cerebrovascular Occlusion; Collateral Blood Circulation; Anterior Cerebral Circulation Infarction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

NBP in thrombolysis group

NBP 25mg bid for 2 weeks administered after 24 hours after receiving recombinant plasminogenactivator(rt-PA) thrombolysis

Group Type: EXPERIMENTAL

NBP

Intervention Type: DRUG

NBP group

NBP 25mg bid for 2 weeks administered for the patients who do not receive rt-PA

Group Type: EXPERIMENTAL

NBP

Intervention Type: DRUG

Control group

Control group not receiving rt-PA thrombolysis, receiving basic therapy for acute stroke, e.g. aspirin/clopidogrel and lipid-lowering therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Control in thrombolysis group

Control group receiving rt-PA thrombolysis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NBP

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men or women ≥ 18 years old;

2. Acute occlusion of M1 or intracranial internal carotid artery within 72 hours;

3. For patients who receive recombinant tissue-type plasminogenactivator therapy, the arterial occlusive lesion scale of 24-72 hours post-thrombolysis imaging should be 0 or 1;

4. Ischemic stroke with National Institutes of Health Stroke Scale ≥ 4;

5. Baseline mRS before this stroke onset less than 2;

6. Able and willing to comply with study requirements;

7. Signed informed consent by patients self or legally authorized representatives.

Exclusion Criteria

1. Cerebral hemorrhage;

2. Posterior circulation infarction;

3. Severe tendency of hemorrhage, such as thrombocytopenia, leukemia, allergic purpura;

4. Currently using urinary kallidinogenase or alprostadil;

5. Be allergic to NBP or celery;

6. Impaired liver function (alanine aminotransferase or glutamic oxalacetic transaminase ≥ 3×upper limit of normal) or renal function (serum creatinie ≥ 1.5mg/dl);

7. Patients with evidence of severe congestive heart failure or history of end-stage cardiovascular disease (e.g. congestive heart failure New York Heart Association Class III or IV);

8. Metastatic neoplasm or multiple organ failure;

9. Pregnancy or breastfeeding;

10. History of mental instability or dementia.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Lou, Ph.D, M.D.

Role: STUDY_CHAIR

second affiliated hospital of Zhejiang University, school of medicine

Locations

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

SAHZJUNeuro

Identifier Type: -

Identifier Source: org_study_id