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Status unknownNCT01558245Updated Sep 12, 2013

Tissue Kallikrein Preventing the Restenosis After Stenting of Symptomatic MCA Atherosclerotic Stenosis

A Phase 2 interventional study of tissue kallikrein in Cerebrovascular Disease, sponsored by Jinling Hospital, China. Status unknown at 1 site in China. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2013-09-12.

Sponsored by Jinling Hospital, China · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study summary

The study aims to determine whether tissue kallikrein (TK) is efficacy for preventing the long-term in-stent restenosis (ISR) after stenting of symptomatic atherosclerotic stenosis of the middle cerebral artery (MCA) M1 segment

Read the detailed description

A series of studies have confirmed the kallikrein-kinin system (KKS), including kallikrein, kininogen and kinin, plays an important role in the regulation of inflammation secondary to acute and chronic ischemic brain injury. Some researchers found that hTK gene delivery can inhibit the formation of neointimal induced by the common carotid artery ligation in mice. Further study revealed hTK gene transfection in VSMC lead to increased secretion of TK and inhibition of VSMC proliferation. In addition, it was also observed that the serum TK levels were coincident with the carotid artery stenosis. The more severe the stenosis is, the higher the serum TK level is, and the serum TK decreased after carotid artery angioplasty and stent placement. These results suggest that KKS play an important regulatory role in vascular remodeling and TK may exert a beneficial influence in the process of ISR

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Conditions studied

  • Cerebrovascular Disease

Keywords

  • ischemic stroke; in-stent restenosis; tissue kallikrein;
  • the middle cerebral artery; atherosclerotic stenosis
03

In context

Cerebrovascular Disorders

385 studies on the registry are indexed under Cerebrovascular Disorders; 129 are open to participants now.

This study's planned enrollment of 99 is close to the median of 109 across 224 interventional studies indexed under Cerebrovascular Disorders.

Browse Cerebrovascular Disorders studies →

Lead sponsor

Jinling Hospital, China is the lead sponsor of 130 studies on the registry; 35 are open to participants now.

Browse Jinling Hospital, China studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. TIA or stroke in the MCA territory refractory to aggressive anti-platelet and regular statin therapy in 3 months
  2. Symptomatic MCA M1 segment stenosis ≥ 70% confirmed with DSA
  3. Successfully treated with PTAS without acute surgical complications in 12 hours after operation
  4. All patients provided fully informed consent

Exclusion criteria

Exclusion Criteria:

  1. Using angiotensin-converting enzyme inhibitors
  2. Severe cardiopulmonary dysfunction, chronic liver disease (A / G inversion, ALT increased 2-fold greater than normal), abnormal renal function (serum creatinine greater than 1.5 times normal)
  3. Allergies, the history of allergy to multi-drug
  4. The history of cerebral hemorrhage, brain tumors, brain trauma, cerebral embolism and other brain lesions
  5. During pregnancy or breast-feeding
  6. Not expected to complete follow-up
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
99 participants (estimated)

Study arms

  • Experimental
    Tissue kallikrein group

    Patients in this group will be prescribed with intravenous infusion of TK (0.15 PNAU/d, dissolved in 100ml saline) for 7 days after stenting and then oral administration of pancreatic kallikrein enteric-coated tablet (240U, 3/d) to the end of study. As the foundation treatment, all the enrolled patients will receive aspirin (100 mg/d), clopidogrel (75 mg/d), and atorvastatin (20 mg/d) for the first 6 months and continue with the combination of aspirin and atorvastatin at the previous dosage.

    Drug: tissue kallikrein

  • No intervention
    Control group

    Patients in control group will receive foundation treatment, including aspirin (100 mg/d), clopidogrel (75 mg/d), and atorvastatin (20 mg/d) for the first 6 months and continue with the combination of aspirin and atorvastatin at the previous dosage.

Interventions

  • Drugtissue kallikrein

    Human urinary kallidinogenase can transform kininogen to bradykinin (kinin) and vasodilatory factors (kallidin)

    Also known as: Human urinary kallidinogenase (HUK)

06

What researchers measure

Primary outcomes

  1. Target lesion failure

    Patients will be evaluated at 1 month, 6 months, and 12 months after the stenting. The primary outcomes are the asymptomatic or symptomatic in-stent restenosis ≥ 50% (affirmed by digital subtraction angiography at 6 and 12 months), new stroke (ischemic and hemorrhagic) or aggravation of the previous ischemic stroke ipsilateral to the severe stenotic artery.

    Time frame: 12 months

Secondary outcomes

  1. Clinical endpoint

    Stroke of other artery territories, myocardial infarction and vascular death will be conducted in-hospital and planned at 1 month, 6 months, and 12 months.

    Time frame: 12 months

Other outcomes

  1. Laboratory data

    Laboratory data including bradykinin (BK), TK, platelet inhibitory rate, cGMP, cAMP, hs-CRP, TNF-α, IL-6, LDL-Ch and HDL-Ch will be recorded

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
    Nanjing, Jiangsu, China
    Recruiting
08

References and documents

Publications

  • Shi R, Zhang R, Yang F, Lin M, Li M, Liu L, Yin Q, Lin H, Xiong Y, Liu W, Fan X, Dai Q, Zhou L, Lan W, Cao Q, Chen X, Xu G, Liu X. Tissue Kallikrein Prevents Restenosis After Stenting of Severe Atherosclerotic Stenosis of the Middle Cerebral Artery: A Randomized Controlled Trial. Medicine (Baltimore). 2016 Feb;95(6):e2809. doi: 10.1097/MD.0000000000002809. PubMed 26871851 ↗
  • Lan W, Yang F, Liu L, Yin Q, Li M, Li Z, Sang H, Xu G, Ma M, Zhang Z, Liu Z, Liu X, Zhang R. Tissue kallikrein preventing the restenosis after stenting of symptomatic MCA atherosclerotic stenosis (KPRASS). Int J Stroke. 2014 Jun;9(4):533-5. doi: 10.1111/ijs.12229. Epub 2013 Dec 20. PubMed 24354519 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2011, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2011
First posted
Mar 20, 2012
Start
Dec 2011
Primary completionEst.
Dec 2013
CompletionEst.
Dec 2013
Last update
Sep 12, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01558245
Lead sponsor
Jinling Hospital, China
Responsible party
Zhang Renliang (Clinical Professor and Associate Director of Department of Neurology, Jinling Hospital, China) — Principal investigator
First posted
Mar 20, 2012
Start date
Dec 2011
Primary completion
Dec 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Sep 12, 2013

Study contacts

Renliang Zhang, MD
Contact
zhangrenliang@gmail.com
+ 86-25-8480386
Renliang Zhang, MD
principal investigator · Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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