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

NCT01558245 | Unknown Phase 2 DMC

• 1 other identifier: KPRASS
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cerebrovascular Disease

Keywords

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

Outcome Measures

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.

  12 months

Secondary Outcomes (1)

• Clinical endpoint

  12 months

Other Outcomes (1)

• Laboratory data

  12 months

Study Arms (2)

Tissue kallikrein group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

tissue kallikrein DRUG

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

Also known as: Human urinary kallidinogenase (HUK)

Tissue kallikrein group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Using angiotensin-converting enzyme inhibitors
• 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)
• Allergies, the history of allergy to multi-drug
• The history of cerebral hemorrhage, brain tumors, brain trauma, cerebral embolism and other brain lesions
• During pregnancy or breast-feeding
• Not expected to complete follow-up

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 26871851 DERIVED

• 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.

  PMID: 24354519 DERIVED

MeSH Terms

Conditions

Cerebrovascular Disorders; Ischemic Stroke

Interventions

Tissue Kallikreins

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke

Intervention Hierarchy (Ancestors)

Kallikreins; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Biomarkers, Tumor; Biomarkers; Biological Factors

Study Officials

• Renliang Zhang, MD

  Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renliang Zhang, MD

CONTACT

+ 86-25-8480386; zhangrenliang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and Associate Director of Department of Neurology

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: March 20, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

CN (1)