Intracranial ArteriosclerosisPhase 4NCT04325932
Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis
A Phase 4 study testing Urinary Kallikrein in people with Intracranial Arteriosclerosis and Collateral Circulation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to determine whether Urinary Kallikrein has an additional effect on enhancing collateral circulation in symptomatic intracranial atherosclerotic patients under clopidogrel and aspirin dual antiplatelet therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Arteriosclerosis, Collateral Circulation, Anterior Cerebral Circulation Infarction
- What is being tested?
- Urinary Kallikrein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke or TIA within 72 hours;
- Intracranial ICA, MCA M1 segment stenosis (>70%)
Who cannot join
- >70% Stenosis in an intracranial artery other than the culprit artery.
- >50% Stenosis of an extracranial carotid or vertebral artery on the ipsilateral side.
- Perforator strokes based on MRI.
- Non-atherosclerotic lesion, for example, moyamoya disease, vascular inflammatory disease due to infection, autoimmunity diseases, developmental or genetic abnormalities, for example, fibromuscular dysplasia, sickle-cell anaemia, suspected vasospasm.
- Potential cardiac embolism as cause.
- Intracranial haemorrhage within 6 weeks.
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- Concomitant intracranial tumour, aneurysm or arteriovenous malformation.
- Known contraindications for heparin, aspirin, clopidogrel or contrast.
- Haemoglobin <10 g/dL, blood platelet count <100 000, international normalisation ratio >1.5, or other uncorrectable coagulopathies.Impaired liver function (alanine aminotransferase or glutamic oxalacetic transaminase ≥ 3×upper limit of normal) or renal function (serum creatinie ≥ 1.5mg/dl);
- A baseline modified Rankin Score of ≥3.
- Life expectancy of <1 year due to the concomitant illness.
- Pregnant or lactating women.
- long-term statins users.
- History of mental instability or dementia.
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis: a Study Based on Whole-brain CTP
The purpose of this study is to determine whether Urinary Kallikrein has an additional effect on enhancing collateral circulation in symptomatic intracranial atherosclerotic patients under clopidogrel and aspirin dual antiplatelet therapy.
- Conditions
- Intracranial Arteriosclerosis, Collateral Circulation, Anterior Cerebral Circulation Infarction
- Being tested
- Urinary Kallikrein
- Medical subject headings
- Intracranial Arteriosclerosis, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary KallikreinDrug
Also called Urinary Kallidinogenase
| Study group | Role | What they receive |
|---|---|---|
| Urinary Kallikrein group | Experimental | Urinary Kallikrein for injection, 0.15PNA IU,qd, for 2 weeks, administered within 96 hours after TIA or acute ischemic stroke, with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy. Receives: Drug: Urinary Kallikrein |
| control group | No intervention | with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2
Measured: 3 months
Secondary outcomes (4)
rLMC scale of Collateral circulation
We use regional leptomeningeal score(rLMC) score to measure collateral circulation.rLMC score is based on scoring pial and lenticulostriate arteries in 6 ASPECTS regions(M1-6) plus anterior cerebral artery region and basal ganglia. Pial arteries in the Sylvian sulcus are scored 0,2, or 4.
Measured: 2 weeks, 1 month
NIHSS score
Measured: 2 weeks, 1month
Hemorrhageic complications
Hemorrhageic complications including intracranial, digestive tract
Measured: 2 weeks, 1 month, 3 months, 6 months
New stroke or transient ischemic attack(TIA)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study startJan 2016
- Primary completionMay 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Lou, Ph.D,M.D., Study chair, second affiliated hospital of Zhejiang University, school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325932
- Sponsor's protocol ID
- UK-001
- Status last verified
- May 2015
- First submitted
- 5 Oct 2017
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis: a Study Based on Whole-brain CTP
- ClinicalTrials.gov ID
- NCT04325932
- Acronym / sponsor ID
- UK-001
- Conditions
- Intracranial Arteriosclerosis, Collateral Circulation, Anterior Cerebral Circulation Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 30 Mar 2020 (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.
The purpose of this study is to determine whether Urinary Kallikrein has an additional effect on enhancing collateral circulation in symptomatic intracranial atherosclerotic patients under clopidogrel and aspirin dual antiplatelet therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary Kallikrein group | Experimental | Drug: Urinary KallikreinUrinary Kallikrein for injection, 0.15PNA IU,qd, for 2 weeks, administered within 96 hours after TIA or acute ischemic stroke, with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy. |
| control group | No intervention | –with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute ischemic stroke or TIA within 72 hours;
- Intracranial ICA, MCA M1 segment stenosis (>70%)
Key exclusion criteria (14 listed)
- >70% Stenosis in an intracranial artery other than the culprit artery.
- >50% Stenosis of an extracranial carotid or vertebral artery on the ipsilateral side.
- Perforator strokes based on MRI.
- Non-atherosclerotic lesion, for example, moyamoya disease, vascular inflammatory disease due to infection, autoimmunity diseases, developmental or genetic abnormalities, for example, fibromuscular dysplasia, sickle-cell anaemia, suspected vasospasm.
- Potential cardiac embolism as cause.
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 |
|---|---|---|
| Urinary KallikreinAlso: Urinary Kallidinogenase | Drug | Urinary Kallikrein group |
Primary outcome
the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2
Time frame: 3 months
4 secondary outcomes
rLMC scale of Collateral circulation
Time frame: 2 weeks, 1 month
NIHSS score
Time frame: 2 weeks, 1month
Hemorrhageic complications
Time frame: 2 weeks, 1 month, 3 months, 6 months
New stroke or transient ischemic attack(TIA)
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- 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.
Min Lou, Ph.D,M.D. study chair
second affiliated hospital of Zhejiang University, school of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Urinary Kallikrein in people with Intracranial Arteriosclerosis and Collateral Circulation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 14 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: withdrawn, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2 (time frame: 3 months). 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 30 Mar 2020.