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

Intracranial Arteriosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04325932
• Other study ID #: UK-001
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: July 2019

Study information

• Verified date: May 2015
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cerebral Circulation Infarction
• Arteriosclerosis
• Atherosclerosis
• Brain Infarction
• Collateral Circulation
• Infarction
• Intracranial Arteriosclerosis

Intervention

Drug:
• Urinary Kallikrein

Locations

Country	Name	City	State
China	The second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2		3 months
Secondary	rLMC scale of Collateral circulation	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.	2 weeks, 1 month
Secondary	NIHSS score		2 weeks, 1month
Secondary	Hemorrhageic complications	Hemorrhageic complications including intracranial, digestive tract	2 weeks, 1 month, 3 months, 6 months
Secondary	New stroke or transient ischemic attack(TIA)		6 months