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

Anterior Cerebral Circulation Infarction Clinical Trial

— INCIMO  

Official title:

The Impact of NBP on the Collateral Circulation in Acute Acute Internal Carotid Artery(ICA)/Middle Cerebral Artery(M1) Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594995
• Other study ID #: SAHZJUNeuro
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2016
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: December 30, 2019
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cerebral Circulation Infarction
• Brain Infarction
• Cerebrovascular Disorders
• Cerebrovascular Occlusion
• Collateral Blood Circulation
• Infarction

Intervention

Drug:
• NBP

Locations

Country	Name	City	State
China	The second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2		3 months
Secondary	rLMC scale of Collateral circulation	We use regional leptomeningeal score(rLMC) score to measure collateral circulation.rLMC score is based on scoring pial and lenticulostriate arteries in 6 ASPECTS regions(M1-6) plus anterior cerebral artery region and basal ganglia. Pial arteries in the Sylvian sulcus are scored 0,2, or 4.	2 weeks, 3 months
Secondary	NIHSS score		1 week, 2 weeks, 3 months
Secondary	Hemorrhageic complications including intracranial, digestive tract		2 weeks, 3 months
Secondary	New stroke or transient ischemic attack(TIA)		3 months
Secondary	complete blood count		3 months