- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04325932
Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis
March 27, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis: a Study Based on Whole-brain CTP
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- The Second Affiliated Hospital of Zhejiang University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Urinary Kallikrein group
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.
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Other Names:
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No Intervention: control group
with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rLMC scale of Collateral circulation
Time Frame: 2 weeks, 1 month
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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.
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2 weeks, 1 month
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NIHSS score
Time Frame: 2 weeks, 1month
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2 weeks, 1month
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Hemorrhageic complications
Time Frame: 2 weeks, 1 month, 3 months, 6 months
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Hemorrhageic complications including intracranial, digestive tract
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2 weeks, 1 month, 3 months, 6 months
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New stroke or transient ischemic attack(TIA)
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Min Lou, Ph.D,M.D., Second Affiliated Hospital of Zhejiang University, School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
May 1, 2019
Study Completion (Actual)
July 1, 2019
Study Registration Dates
First Submitted
October 5, 2017
First Submitted That Met QC Criteria
March 27, 2020
First Posted (Actual)
March 30, 2020
Study Record Updates
Last Update Posted (Actual)
March 30, 2020
Last Update Submitted That Met QC Criteria
March 27, 2020
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arterial Occlusive Diseases
- Brain Ischemia
- Stroke
- Intracranial Arterial Diseases
- Infarction
- Arteriosclerosis
- Atherosclerosis
- Brain Infarction
- Intracranial Arteriosclerosis
- Physiological Effects of Drugs
- Coagulants
- Reproductive Control Agents
- Fertility Agents
- Fertility Agents, Male
- Kallikreins
Other Study ID Numbers
- UK-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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