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Trial record 41 of 458 for:    ASPIRIN AND clopidogrel AND ischemic

Evaluation Of HUK in Acute Stroke Patients: MRS and CTP

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ClinicalTrials.gov Identifier: NCT03431909
Recruitment Status : Completed
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

Brief Summary:

Background: Acute ischemic stroke (AIS) is a leading cause of morbidity and mortality worldwide. Human urinary kallidinogenase (HUK), a glycoprotein extracted from male urine currently used in China for enhancing cerebral perfusion5, plays a neuroprotective role including promoting angiogenesis, enhancing cerebral perfusion and suppressing the inflammatory response in animals and in patients with respect to regulating the kallikrein-kinin system. In previous clinical research, neurological function scores and cerebral perfusion scans were largely used to evaluate the efficiency of HUK. However, the mechanisms of Further well-conducted, randomized controlled studies using HUK are currently lacking.

Objective: To assess the Human urinary kallidinogenase effects on brain metabolite and cerebral perfusion changes using magnetic resonance spectroscopy and CT perfusion in patients with AIS.

Methods: The investigators plan to do a single-centre randomized, double-blind, controlled trial in which ischemic stroke patients will be randomized to treatment with either HUK or regular treatment within 72 hours of symptom onset. The study includes two MRS and two CTP scannings (before and after 2 week treatment) for all randomized subjects.

The endpoints will include improvement of the NIH Stroke Scale (NIHSS) score from baseline, modified Rankin scale (mRS) score and Barthel index at 14 days.

EvHUKMRS will test the following hypotheses:

  1. HUK enhanced N-acetylaspartate (NAA) and cerebral blood flow (CBF) 14 days after treatment compared with control group.
  2. HUK group compared to control group when administered 72 hours after onset of AIS improves recovery and functional outcome as assessed by improvement of NIHSS score , mRS score and BI score on day 14 post-stroke.

A positive result will have a significant impact in the management of AIS and pave the way for future studies aimed at finding the optimal dose and formulation of HUK for treating acute ischemic stroke.


Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: Human urinary kallidinogenase (HUK) Drug: aspirin® , clopidogrel® , atorvastatin® Phase 4

Detailed Description:

A)Specific Primary Objective:

1. To determine if HUK, administered within 72 hours of AIS onset is superior to regular treatment in improving NAA values and CBF on day 14 post stroke.

B) Specific Secondary Objectives:

1. To determine if HUK, administered within 72 hours of AIS onset is superior to regular treatment in reducing neurological deficit and improving functional outcome on day 14 post stroke.

Recruitment of study subjects:

Acute ischemic stroke patients admitted to the Neurology department in XWh (Xuan hospital) during the study period who are eligible to participate in this study based on criteria stated above will be invited to participate in this study.

The time window for enrolment will be within 72 hours of symptom onset. All eligible patients will be identified by the ward and on-call Neurology/Medical teams and referred to the study research assistants or investigators; who will then screen the patient for participation in this trial.

STUDY INTERVENTION The assigned treatment 0.15 PNA units of HUK injection or regular treatment will be administered once daily for 14 consecutive days soon after informed consent is taken and the patient is enrolled into the study.

Follow-up Assessment:

The neurologic deficits, global functional abilities and level of handicap will be scored using the NIH Stroke Scale (NIHSS) and the modified Rankin scale (mRS) at baseline and on day 14(plus or minus 14 days).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation Of Human Urinary Kallidinogenase in Acute Stroke Patients: Magnetic Resonance Spectrum and CT Perfusion
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : October 1, 2016
Actual Study Completion Date : October 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kallikrein group
Subjects receive kailikang treatment according to real clinical practice (suggest above 14 days treatment),0.15 peptide nucleic acids(PNA), once a day.
Drug: Human urinary kallidinogenase (HUK)
Human urinary kallidinogenase can transform kininogen to bradykinin (kinin) and vasodilatory factors (kallidin)

Sham Comparator: 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 14 days
Drug: aspirin® , clopidogrel® , atorvastatin®
Patients in control group will receive foundation treatment, including aspirin® (100 mg/d), clopidogrel® (75 mg/d), and atorvastatin® (20 mg/d) for 14 days




Primary Outcome Measures :
  1. N-acetylaspartate as measured on Magnetic Resonance Spectrum study on admission [ Time Frame: 14 days ]
    NAA Admit

  2. Creatine as measured on Magnetic Resonance Spectrum study on admission [ Time Frame: 14 days ]
    Cr Admit

  3. Cholineas measured on Magnetic Resonance Spectrum study on admission [ Time Frame: 14 days ]
    Cho


Secondary Outcome Measures :
  1. The proportion of mordified Rankin Scale [ Time Frame: 14 days ]
  2. The proportion of NIHSS [ Time Frame: 14 days ]
  3. The proportion of mRS [ Time Frame: 14 days ]
  4. Cerebral blood flow as measured on CT perfusion study on admission [ Time Frame: 14 days ]
    CBF Admit

  5. Cerebral blood volume as measured on CT perfusion study on admission [ Time Frame: 14 days ]
    CBV Admit

  6. Mean transit time as measured on CT perfusion study on admission [ Time Frame: 14 days ]
    MTT Admit

  7. Time to peak as measured on CT perfusion study on admission [ Time Frame: 14 days ]
    TTP Admit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages ranging from 18 to 80 years
  • onset time less than 72 h, NIHSS score ≥4;

Exclusion Criteria:

  • TIA
  • patients with contraindication of venous thrombolysis
  • patients with encephalic bleeding disorder
  • patients with incomplete hepatic and renal function
  • patients with a medical history of peptic ulcer, haemorrhagic stroke, brain tumour or brain trauma
  • patients who could not coordinate with an MRS scan and
  • patients with vertebral basilar artery system infarction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431909


Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Study Chair: Moli Wang, 1 Xuanwu Hospital, Beijing

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Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03431909     History of Changes
Other Study ID Numbers: mrsctpzyf
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xuanwu Hospital, Beijing:
Human Urinary Kallidinogenase
Acute ischemic stroke
Magnetic resonance spectroscopy
CT perfusion

Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin
Kallikreins
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents