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

Primary Purpose

Cerebrovascular Occlusion, Collateral Blood Circulation, Anterior Cerebral Circulation Infarction

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
NBP
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebrovascular Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The second affiliated hospital of Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

NBP in thrombolysis group

NBP group

Control group

Control in thrombolysis group

Arm Description

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

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

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

Control group receiving rt-PA thrombolysis

Outcomes

Primary Outcome Measures

the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2

Secondary Outcome Measures

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.
NIHSS score
Hemorrhageic complications including intracranial, digestive tract
New stroke or transient ischemic attack(TIA)
complete blood count

Full Information

First Posted
October 22, 2015
Last Updated
March 27, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT02594995
Brief Title
The Impact of NBP on the Collateral Circulation in ICA/M1 Occlusion
Acronym
INCIMO
Official Title
The Impact of NBP on the Collateral Circulation in Acute Acute Internal Carotid Artery(ICA)/Middle Cerebral Artery(M1) Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Occlusion, Collateral Blood Circulation, Anterior Cerebral Circulation Infarction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NBP in thrombolysis group
Arm Type
Experimental
Arm Description
NBP 25mg bid for 2 weeks administered after 24 hours after receiving recombinant plasminogenactivator(rt-PA) thrombolysis
Arm Title
NBP group
Arm Type
Experimental
Arm Description
NBP 25mg bid for 2 weeks administered for the patients who do not receive rt-PA
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group not receiving rt-PA thrombolysis, receiving basic therapy for acute stroke, e.g. aspirin/clopidogrel and lipid-lowering therapy
Arm Title
Control in thrombolysis group
Arm Type
No Intervention
Arm Description
Control group receiving rt-PA thrombolysis
Intervention Type
Drug
Intervention Name(s)
NBP
Primary Outcome Measure Information:
Title
the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2
Time Frame
3 months
Secondary Outcome Measure Information:
Title
rLMC scale of Collateral circulation
Description
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.
Time Frame
2 weeks, 3 months
Title
NIHSS score
Time Frame
1 week, 2 weeks, 3 months
Title
Hemorrhageic complications including intracranial, digestive tract
Time Frame
2 weeks, 3 months
Title
New stroke or transient ischemic attack(TIA)
Time Frame
3 months
Title
complete blood count
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women ≥ 18 years old; Acute occlusion of M1 or intracranial internal carotid artery within 72 hours; 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; Ischemic stroke with National Institutes of Health Stroke Scale ≥ 4; Baseline mRS before this stroke onset less than 2; Able and willing to comply with study requirements; Signed informed consent by patients self or legally authorized representatives. Exclusion Criteria: Cerebral hemorrhage; Posterior circulation infarction; Severe tendency of hemorrhage, such as thrombocytopenia, leukemia, allergic purpura; Currently using urinary kallidinogenase or alprostadil; Be allergic to NBP or celery; Impaired liver function (alanine aminotransferase or glutamic oxalacetic transaminase ≥ 3×upper limit of normal) or renal function (serum creatinie ≥ 1.5mg/dl); 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); Metastatic neoplasm or multiple organ failure; Pregnancy or breastfeeding; History of mental instability or dementia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Lou, Ph.D, M.D.
Organizational Affiliation
second affiliated hospital of Zhejiang University, school of medicine
Official's Role
Study Chair
Facility Information:
Facility Name
The second affiliated hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

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

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