Back to resultsStudy of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis
Primary Purpose
Intracranial Arteriosclerosis, Collateral Circulation, Anterior Cerebral Circulation Infarction
Status
Withdrawn
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Urinary Kallikrein
Sponsored by
About this trial
This is an interventional basic science trial for Intracranial Arteriosclerosis
Eligibility Criteria
Inclusion Criteria:
- Acute ischemic stroke or TIA within 72 hours;
- Intracranial ICA, MCA M1 segment stenosis (>70%)
Exclusion Criteria:
- >70% Stenosis in an intracranial artery other than the culprit artery.
- >50% Stenosis of an extracranial carotid or vertebral artery on the ipsilateral side.
- Perforator strokes based on MRI.
- Non-atherosclerotic lesion, for example, moyamoya disease, vascular inflammatory disease due to infection, autoimmunity diseases, developmental or genetic abnormalities, for example, fibromuscular dysplasia, sickle-cell anaemia, suspected vasospasm.
- Potential cardiac embolism as cause.
- Intracranial haemorrhage within 6 weeks.
- Concomitant intracranial tumour, aneurysm or arteriovenous malformation.
- Known contraindications for heparin, aspirin, clopidogrel or contrast.
- Haemoglobin <10 g/dL, blood platelet count <100 000, international normalisation ratio >1.5, or other uncorrectable coagulopathies.Impaired liver function (alanine aminotransferase or glutamic oxalacetic transaminase ≥ 3×upper limit of normal) or renal function (serum creatinie ≥ 1.5mg/dl);
- A baseline modified Rankin Score of ≥3.
- Life expectancy of <1 year due to the concomitant illness.
- Pregnant or lactating women.
- long-term statins users.
- History of mental instability or dementia.
Sites / Locations
- The second affiliated hospital of Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Urinary Kallikrein group
control group
Arm Description
Urinary Kallikrein for injection, 0.15PNA IU,qd, for 2 weeks, administered within 96 hours after TIA or acute ischemic stroke, with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy.
with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy.
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
Hemorrhageic complications including intracranial, digestive tract
New stroke or transient ischemic attack(TIA)
Full Information
NCT ID
NCT04325932
First Posted
October 5, 2017
Last Updated
March 27, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04325932
Brief Title
Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis
Official Title
Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis: a Study Based on Whole-brain CTP
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Study Start Date
January 2016 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
July 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
The purpose of this study is to determine whether Urinary Kallikrein has an additional effect on enhancing collateral circulation in symptomatic intracranial atherosclerotic patients under clopidogrel and aspirin dual antiplatelet therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Arteriosclerosis, Collateral 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
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urinary Kallikrein group
Arm Type
Experimental
Arm Description
Urinary Kallikrein for injection, 0.15PNA IU,qd, for 2 weeks, administered within 96 hours after TIA or acute ischemic stroke, with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy.
Arm Title
control group
Arm Type
No Intervention
Arm Description
with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy.
Intervention Type
Drug
Intervention Name(s)
Urinary Kallikrein
Other Intervention Name(s)
Urinary Kallidinogenase
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, 1 month
Title
NIHSS score
Time Frame
2 weeks, 1month
Title
Hemorrhageic complications
Description
Hemorrhageic complications including intracranial, digestive tract
Time Frame
2 weeks, 1 month, 3 months, 6 months
Title
New stroke or transient ischemic attack(TIA)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute ischemic stroke or TIA within 72 hours;
Intracranial ICA, MCA M1 segment stenosis (>70%)
Exclusion Criteria:
>70% Stenosis in an intracranial artery other than the culprit artery.
>50% Stenosis of an extracranial carotid or vertebral artery on the ipsilateral side.
Perforator strokes based on MRI.
Non-atherosclerotic lesion, for example, moyamoya disease, vascular inflammatory disease due to infection, autoimmunity diseases, developmental or genetic abnormalities, for example, fibromuscular dysplasia, sickle-cell anaemia, suspected vasospasm.
Potential cardiac embolism as cause.
Intracranial haemorrhage within 6 weeks.
Concomitant intracranial tumour, aneurysm or arteriovenous malformation.
Known contraindications for heparin, aspirin, clopidogrel or contrast.
Haemoglobin <10 g/dL, blood platelet count <100 000, international normalisation ratio >1.5, or other uncorrectable coagulopathies.Impaired liver function (alanine aminotransferase or glutamic oxalacetic transaminase ≥ 3×upper limit of normal) or renal function (serum creatinie ≥ 1.5mg/dl);
A baseline modified Rankin Score of ≥3.
Life expectancy of <1 year due to the concomitant illness.
Pregnant or lactating women.
long-term statins users.
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
Plan to Share IPD
No
Learn more about this trial
Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis
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