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

Phase 4

Withdrawn

• Conditions: Anterior Cerebral Circulation Infarction; Collateral Circulation; Intracranial Arteriosclerosis
• Interventions: Drug: Urinary Kallikrein

• Registration Number: NCT04325932
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-05
• Study Start: 2016-01
• Study First Submitted: 2017-10-05
• Primary Completion: 2019-05
• Study Completion: 2019-07
• Study First Submitted QC: 2020-03-27
• Last Update Submitted: 2020-03-27
• Study First Posted: 2020-03-30
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Urinary Kallikrein group	Urinary Kallikrein	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.

Primary Outcome Measures

Name	Time	Method
the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2	3 months

Secondary Outcome Measures

Name	Time	Method
NIHSS score	2 weeks, 1month
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.
New stroke or transient ischemic attack(TIA)	6 months
Hemorrhageic complications	2 weeks, 1 month, 3 months, 6 months	Hemorrhageic complications including intracranial, digestive tract

Trial Locations

Locations (1)

The second affiliated hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China