Back to results

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

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:

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.

Sites / Locations

The second affiliated hospital of Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

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

NCT ID

NCT02594995

First Posted

October 22, 2015

Last Updated

March 27, 2020

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs