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Kallikrein for Preventing Restenosis After Symptomatic Stenosis of MCA M1 Segment Stenting

This study is currently recruiting participants.
Verified January 2013 by Jinling Hospital, China
Sponsor:
Information provided by (Responsible Party):
Zhang Renliang, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01558245
First received: December 14, 2011
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to determine whether kallikrein is effective for Preventing Restenosis after Symptomatic Stenosis of MCA M1 Segment Stenting.


Condition Intervention Phase
Restenosis
 Drug: kallikrein
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Kallikrein for Preventing Restenosis After Symptomatic Stenosis of MCA M1 Segment Stenting

Further study details as provided by Jinling Hospital, China:

Primary Outcome Measures:
  • Restenosis rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kallikrein group
Patients receive continuous infusions of Kallikrein(0.15 PNAU/d， Dissolved in 100ml saline) for 7 days after stenting, with accompanied aspirin(100 mg/d), clopidogrel(75 mg/d, for 6 months) and atorvastatin(20 mg/d) treatment, following by Pancreatic Kinionogenase Enteric-coated Tab(240U, oral, 3/d), to the end of study
 Drug: kallikrein
kallikrein can change kininogen into bradykinin (kinin) and vasodilatory factors (kallidin)
Other Name: Urinary Kallidinogenase
No Intervention: Control group
Patients in control group will not receive kallikrein treatment while receive aspirin(100 mg/d), clopidogrel(75 mg/d, for 6 months) and atorvastatin(20 mg/d)

Detailed Description:

Ischemic stroke is a significant cause of death. Most of the patients are caused by atherosclerosis. Current treatments include internal medicine medications, interventional treatment and so on. Among them, the interventional therapy can make narrow blood vessels blood recovery fastly,and for its small trauma,gradually accepted by neurologists. But in-stent restenosis has become the main obstacle of its application. At present, there is non definite intervention to prevent in-stent restenosis.How to effectively reduce the postoperative restenosis become the majority concern of patients and doctors. Urinary kallidinogenase, one kind of proteolytic enzymes, was extracted from human urine. It can catalyze kininogen into bradykinin (kinin) and vasodilatory factors (kallidin), with extensive effects of arterial vasodilation, inhibiting platelet aggregation, enhancing red blood cell deformability and oxygen dissociation capacity and regulating inflammation which may be the main factor of the in-stent restenosis.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSA examination to determine the symptomatic MCA M1 segment stenosis ≥ 70%, and by platelet aggregation inhibitors and regular statin therapy ineffective in 3 months.
  2. Without surgical contraindications, in line with SAMMPRIS test stenting indications, approved by the hospital ethics committee, patients who are successful treated with stent.
  3. Signed informed consent.

Exclusion Criteria:

  1. Use of 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, allergy to the history of multi-drug.
  4. A 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558245

Contacts
Contact: Zhang ren liang, doctor + 86-25-8480386 zhangrenliang@gmail.com

Locations
China, Jiangsu
Nan jing University Recruiting
Nanjing, Jiangsu, China
Contact: Zhang ren liang, Doctor     + 86-25-8480386     zhangrenliang@gmail.com    
Sponsors and Collaborators
Jinling Hospital, China
Investigators
Principal Investigator: Zhang ren liang, doctor Jinling Hospital, China
  More Information

No publications provided

Responsible Party: Zhang Renliang, Clinical Professor and Associate Director of Department of Neurology, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01558245     History of Changes
Other Study ID Numbers: KPRASS
Study First Received: December 14, 2011
Last Updated: January 14, 2013
Health Authority: China: Ministry of Health

Keywords provided by Jinling Hospital, China:
kallikrein

Additional relevant MeSH terms:
Kallikreins
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Fertility Agents, Male
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013