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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04325932

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Arteriosclerosis Collateral Circulation Anterior Cerebral Circulation Infarction	Drug: Urinary Kallikrein	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis: a Study Based on Whole-brain CTP

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

May 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

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.	Drug: Urinary Kallikrein Other Names: Urinary Kallidinogenase
No Intervention: control group with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy.

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.

Drug: Urinary Kallikrein

Other Names:

Urinary Kallidinogenase

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2 [3 months]

Secondary Outcome Measures

rLMC scale of Collateral circulation [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.
NIHSS score [2 weeks, 1month]
Hemorrhageic complications [2 weeks, 1 month, 3 months, 6 months]
Hemorrhageic complications including intracranial, digestive tract
New stroke or transient ischemic attack(TIA) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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);