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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Intracranial Arteriosclerosis Collateral Circulation Anterior Cerebral Circulation Infarction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Urinary Kallikrein

Intervention Type DRUG

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Urinary Kallikrein

Intervention Type DRUG

Other Intervention Names

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Urinary Kallidinogenase

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No