Acute Ischemic StrokePhase 4NCT03431909
Evaluation Of HUK in Acute Stroke Patients: MRS and CTP
A Phase 4 study testing Human urinary kallidinogenase (HUK) and aspirin® , clopidogrel® , atorvastatin® in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Human urinary kallidinogenase (HUK) and aspirin® , clopidogrel® , atorvastatin®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Oct 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages ranging from 18 to 80 years
- onset time less than 72 h, NIHSS score ≥4;
Who cannot join
- 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.
About this study
Official title: Evaluation Of Human Urinary Kallidinogenase in Acute Stroke Patients: Magnetic Resonance Spectrum and CT Perfusion
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.
Read more
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:
- HUK enhanced N-acetylaspartate (NAA) and cerebral blood flow (CBF) 14 days after treatment compared with control group.
- 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.
Read the detailed description
A)Specific Primary Objective:
- 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.
- Specific Secondary Objectives:
- 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).
- Conditions
- Acute Ischemic Stroke
- Being tested
- Human urinary kallidinogenase (HUK), aspirin® , clopidogrel® , atorvastatin®
- Keywords
- Human Urinary Kallidinogenase, Acute ischemic stroke, Magnetic resonance spectroscopy, CT perfusion
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human urinary kallidinogenase (HUK)Drug
Human urinary kallidinogenase can transform kininogen to bradykinin (kinin) and vasodilatory factors (kallidin)
aspirin® , clopidogrel® , atorvastatin®Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Kallikrein group | Experimental | Subjects receive kailikang treatment according to real clinical practice (suggest above 14 days treatment),0.15 peptide nucleic acids(PNA), once a day. Receives: Drug: Human urinary kallidinogenase (HUK) |
| Control group | Sham comparator | 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 Receives: Drug: aspirin® , clopidogrel® , atorvastatin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-acetylaspartate as measured on Magnetic Resonance Spectrum study on admission
NAA Admit
Measured: 14 days
Creatine as measured on Magnetic Resonance Spectrum study on admission
Cr Admit
Measured: 14 days
Cholineas measured on Magnetic Resonance Spectrum study on admission
Cho
Measured: 14 days
Secondary outcomes (7)
The proportion of mordified Rankin Scale
Measured: 14 days
The proportion of NIHSS
Measured: 14 days
The proportion of mRS
Measured: 14 days
Cerebral blood flow as measured on CT perfusion study on admission
CBF Admit
Measured: 14 days
Cerebral blood volume as measured on CT perfusion study on admission
CBV Admit
Measured: 14 days
Mean transit time as measured on CT perfusion study on admission
MTT Admit
Measured: 14 days
Time to peak as measured on CT perfusion study on admission
TTP Admit
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Jan 2014
- Primary completion1 Oct 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moli Wang, 1, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431909
- Sponsor's protocol ID
- mrsctpzyf
- Status last verified
- Nov 2017
- First submitted
- 5 Dec 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Human Urinary Kallidinogenase in Acute Stroke Patients: Magnetic Resonance Spectrum and CT Perfusion
- ClinicalTrials.gov ID
- NCT03431909
- Acronym / sponsor ID
- mrsctpzyf
- Conditions
- Acute Ischemic Stroke
- Keywords
- Human Urinary Kallidinogenase, Acute ischemic stroke, Magnetic resonance spectroscopy, CT perfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- HUK enhanced N-acetylaspartate (NAA) and cerebral blood flow (CBF) 14 days after treatment compared with control group.
- 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.
Detailed description
A)Specific Primary Objective:
- 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.
- Specific Secondary Objectives:
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kallikrein group | Experimental | Drug: Human urinary kallidinogenase (HUK)Subjects receive kailikang treatment according to real clinical practice (suggest above 14 days treatment),0.15 peptide nucleic acids(PNA), once a day. |
| Control group | Sham comparator | 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ages ranging from 18 to 80 years
- onset time less than 72 h, NIHSS score ≥4;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human urinary kallidinogenase (HUK)Human urinary kallidinogenase can transform kininogen to bradykinin (kinin) and vasodilatory factors (kallidin) | Drug | Kallikrein group |
| 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 | Drug | Control group |
Primary outcome
N-acetylaspartate as measured on Magnetic Resonance Spectrum study on admission
Time frame: 14 days
NAA Admit
Creatine as measured on Magnetic Resonance Spectrum study on admission
Time frame: 14 days
Cr Admit
Cholineas measured on Magnetic Resonance Spectrum study on admission
Time frame: 14 days
Cho
7 secondary outcomes
The proportion of mordified Rankin Scale
Time frame: 14 days
The proportion of NIHSS
Time frame: 14 days
The proportion of mRS
Time frame: 14 days
Cerebral blood flow as measured on CT perfusion study on admission
Time frame: 14 days
Cerebral blood volume as measured on CT perfusion study on admission
Time frame: 14 days
Mean transit time as measured on CT perfusion study on admission
Time frame: 14 days
Time to peak as measured on CT perfusion study on admission
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moli Wang, 1 study chair
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human urinary kallidinogenase (HUK) and aspirin® , clopidogrel® , atorvastatin® in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-acetylaspartate as measured on Magnetic Resonance Spectrum study on admission (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.