NCT04325932

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
Last Updated

March 30, 2020

Status Verified

May 1, 2015

Enrollment Period

3.3 years

First QC Date

October 5, 2017

Last Update Submit

March 27, 2020

Conditions

Intracranial ArteriosclerosisCollateral CirculationAnterior Cerebral Circulation Infarction

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (4)

  • rLMC scale of Collateral circulation

    2 weeks, 1 month

  • NIHSS score

    2 weeks, 1month

  • Hemorrhageic complications

    2 weeks, 1 month, 3 months, 6 months

  • New stroke or transient ischemic attack(TIA)

    6 months

Study Arms (2)

Urinary Kallikrein group

EXPERIMENTAL

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.

Drug: Urinary Kallikrein

control group

NO INTERVENTION

with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy.

Interventions

Urinary KallikreinDRUG
Also known as: Urinary Kallidinogenase
Urinary Kallikrein group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \>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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Intracranial ArteriosclerosisBrain Infarction

Interventions

Tissue Kallikreins

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaStrokeInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

KallikreinsSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesBiomarkers, TumorBiomarkersBiological Factors

Study Officials

  • Min Lou, Ph.D,M.D.

    second affiliated hospital of Zhejiang University, school of medicine

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2017

First Posted

March 30, 2020

Study Start

January 1, 2016

Primary Completion

May 1, 2019

Study Completion

July 1, 2019

Last Updated

March 30, 2020

Record last verified: 2015-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)