Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis

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

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

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The Second Affiliated Hospital of Zhejiang University

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:

  1. Acute ischemic stroke or TIA within 72 hours;
  2. Intracranial ICA, MCA M1 segment stenosis (>70%)

Exclusion Criteria:

  1. >70% Stenosis in an intracranial artery other than the culprit artery.
  2. >50% Stenosis of an extracranial carotid or vertebral artery on the ipsilateral side.
  3. Perforator strokes based on MRI.
  4. 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.
  5. Potential cardiac embolism as cause.
  6. Intracranial haemorrhage within 6 weeks.
  7. Concomitant intracranial tumour, aneurysm or arteriovenous malformation.
  8. Known contraindications for heparin, aspirin, clopidogrel or contrast.
  9. 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);
  10. A baseline modified Rankin Score of ≥3.
  11. Life expectancy of <1 year due to the concomitant illness.
  12. Pregnant or lactating women.
  13. long-term statins users.
  14. 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.
Other Names:
  • Urinary Kallidinogenase
No Intervention: control group
with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy.

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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rLMC scale of Collateral circulation
Time Frame: 2 weeks, 1 month
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 weeks, 1 month
NIHSS score
Time Frame: 2 weeks, 1month
2 weeks, 1month
Hemorrhageic complications
Time Frame: 2 weeks, 1 month, 3 months, 6 months
Hemorrhageic complications including intracranial, digestive tract
2 weeks, 1 month, 3 months, 6 months
New stroke or transient ischemic attack(TIA)
Time Frame: 6 months
6 months

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

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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