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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02594995
• Collaborator: (none)
• Enrollment: 311
• Location: 1
• Arms: 4
• Duration (Months): 54
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Occlusion; Collateral Blood Circulation; Anterior Cerebral Circulation Infarction	Drug: NBP	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 311 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Impact of NBP on the Collateral Circulation in Acute Acute Internal Carotid Artery(ICA)/Middle Cerebral Artery(M1) Occlusion
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Dec 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NBP in thrombolysis group NBP 25mg bid for 2 weeks administered after 24 hours after receiving recombinant plasminogenactivator(rt-PA) thrombolysis	Drug: NBP
Experimental: NBP group NBP 25mg bid for 2 weeks administered for the patients who do not receive rt-PA	Drug: NBP
No Intervention: Control group Control group not receiving rt-PA thrombolysis, receiving basic therapy for acute stroke, e.g. aspirin/clopidogrel and lipid-lowering therapy
No Intervention: Control in thrombolysis group Control group receiving rt-PA thrombolysis

Outcome Measures

Primary Outcome Measures

1. the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2 [3 months]

Secondary Outcome Measures

1. rLMC scale of Collateral circulation [2 weeks, 3 months]

   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. NIHSS score [1 week, 2 weeks, 3 months]

3. Hemorrhageic complications including intracranial, digestive tract [2 weeks, 3 months]

4. New stroke or transient ischemic attack(TIA) [3 months]

5. complete blood count [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

• Study Chair: Min Lou, Ph.D, M.D., second affiliated hospital of Zhejiang University, school of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT02594995
• Other Study ID Numbers: SAHZJUNeuro
• First Posted: Nov 3, 2015
• Last Update Posted: Mar 31, 2020
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Brain Infarction; Cerebrovascular Disorders; Infarction

Study Results

No Results Posted as of Mar 31, 2020