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

Zhejiang University

Status and phase: Withdrawn; Phase 4

Conditions: Anterior Cerebral Circulation Infarction; Intracranial Arteriosclerosis; Collateral Circulation

Treatments: Drug: Urinary Kallikrein

Study type: Interventional

Funder types: Other

Identifiers

NCT04325932

UK-001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Urinary Kallikrein group

Experimental group

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.

Treatment:

Drug: Urinary Kallikrein

control group

No Intervention group

Description:

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