Acute Ischemic StrokeNCT06137300
Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke
A study testing Urinary kallidinogenase for injection and Guideline-prescribed medical therapy in people with Acute Ischemic Stroke, run by Yi Yang at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Urinary kallidinogenase for injection and Guideline-prescribed medical therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 986 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years old;
- Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score ≥6, ≤15;
- Moderate to severe stenosis or occlusion of offending vessels;
- The mRS Score ≤2 before onset;
- Subjects or their legal representatives agreed to the treatment and signed the informed consent form.
Who cannot join
- Transient ischemic attack;
- Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy);
- Severe disturbance of consciousness:GCS ≤8;
- Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly;
- Refractory hypertension: systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg; hypotension: systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg;
- Liver dysfunction (ALT/AST >1.5 × upper limit of normal [ULN]), renal dysfunction (Cr >1 × ULN);
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- Coagulopathy (prolonged INR (>1.5) or prolonged APTT (>2 folds);
- Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.);
- Special populations such as pregnant and lactating women, patients with life expectancy less than 3 months, or patients unable to complete the study for other reasons;
- Unwilling to be followed up or poor treatment compliance;
- Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment;
- Other conditions considered by the investigator to be inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD,PhD, 13756661217 ext. 0086, doctoryangyi@163.com
Zhenni Guo, MD,PhD, 18186872986 ext. 0086, zhen1ni2@163.com
About this study
Official title: Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke：a Multicentre, Prospective, Randomised, Open-label, Blinded-Endpoint Trial
The purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.
Read the detailed description
Currently, evidence regarding the safety and efficacy of urinary kallidinogenase treatment in patients with acute ischemic stroke lacks, and few of related studies were large-scale and high-quality. Thus, this study was designed to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Urinary kallidinogenase for injection, Guideline-prescribed medical therapy
- Keywords
- Acute Ischemic Stroke, Urinary Kallidinogenase
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary kallidinogenase for injectionDrug
Also called Guideline-prescribed medical therapy
Urinary kallidinogenase 0.15PNA once daily for 7 days.
Guideline-prescribed medical therapyOther
Guideline-prescribed medical therapy
| Study group | Role | What they receive |
|---|---|---|
| Urinary Kallidinogenase group | Experimental | Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy. Receives: Drug: Urinary kallidinogenase for injection |
| Control group | Other | Patients are only treated with guideline-prescribed basic medical therapy. Receives: Other: Guideline-prescribed medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
Measured: 90 days
Secondary outcomes (3)
National Institute of Health Stroke Scale (NIHSS) at 7days.
National Institute of Health stroke Scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
Measured: 7days
Incidence of ischemic stroke within 90 days.
Including recurrent and new ischemic stroke.
Measured: 0-90days
Adverse events occurring in the course of the treatment.
Including all adverse events, severe adverse events and urinary kallidinogenase related adverse events.
Measured: 0-7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Mar 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 986 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
- Investigators
- Yi Yang, MD,PhD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137300
- Sponsor's protocol ID
- TK-LAA
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke：a Multicentre, Prospective, Randomised, Open-label, Blinded-Endpoint Trial
- ClinicalTrials.gov ID
- NCT06137300
- Acronym / sponsor ID
- TK-LAA
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Urinary Kallidinogenase
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 986 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Nov 2023 (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 evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.
Detailed description
Currently, evidence regarding the safety and efficacy of urinary kallidinogenase treatment in patients with acute ischemic stroke lacks, and few of related studies were large-scale and high-quality. Thus, this study was designed to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary Kallidinogenase group | Experimental | Drug: Urinary kallidinogenase for injectionPatients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy. |
| Control group | Other | Other: Guideline-prescribed medical therapyPatients are only treated with guideline-prescribed basic medical therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old;
- Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score ≥6, ≤15;
- Moderate to severe stenosis or occlusion of offending vessels;
- The mRS Score ≤2 before onset;
- Subjects or their legal representatives agreed to the treatment and signed the informed consent form.
Key exclusion criteria (12 listed)
- Transient ischemic attack;
- Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy);
- Severe disturbance of consciousness:GCS ≤8;
- Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly;
- Refractory hypertension: systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg; hypotension: systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg;
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 kallidinogenase for injectionAlso: Guideline-prescribed medical therapyUrinary kallidinogenase 0.15PNA once daily for 7 days. | Drug | Urinary Kallidinogenase group |
| Guideline-prescribed medical therapyGuideline-prescribed medical therapy | Other | Control group |
Primary outcome
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
Time frame: 90 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
3 secondary outcomes
National Institute of Health Stroke Scale (NIHSS) at 7days.
Time frame: 7days
Incidence of ischemic stroke within 90 days.
Time frame: 0-90days
Adverse events occurring in the course of the treatment.
Time frame: 0-7days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
Yi Yang, MD,PhD principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary kallidinogenase for injection and Guideline-prescribed medical therapy in people with Acute Ischemic Stroke, run by Yi Yang 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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 28 Feb 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang, MD,PhD (13756661217 ext. 0086, doctoryangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days (time frame: 90 days). 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 28 Feb 2024.