Acute Ischemic StrokeHEALNCT06211712
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
A study testing Experimental: Human Urinary Kallidinogenase in people with Acute Ischemic Stroke, run by Huashan Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Human Urinary Kallidinogenase combined with endovascular therapy in acute ischemic stroke (AIS) patients with large vessel occlusion. 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?
- Experimental: Human Urinary Kallidinogenase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2024to Dec 2025
- 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
- Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged).
- Age ≥18 years old.
- The mRS score was 0-1 before onset.
- ASPECT score of infarction on emergency CT ≥7.
- Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery).
- Emergency CTP or DWI suggesting infarct core body ≥10 mL and <100 mL, and low perfusion brain tissue volume/ infarct core volume> 1.2.
- Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate).
Who cannot join
- Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications.
- CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.).
- Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases.
- Taking ACEI antihypertensive drugs regularly and could not stop.
- Participant with major surgery or severe trauma in the past 2 weeks.
- Poor compliance and cannot fully follow the study protocol.
- Pregnancy or lactation.
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, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, 200040
Qiang Dong, M.D., 13701747065, 13701747065@163.com
Wenjie Cao, M.D., 13918206324, wenjiecao@fudan.edu.cn
About this study
Official title: Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion: A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Study
The purpose of this study is to evaluate the safety and efficacy of Human Urinary Kallidinogenase combined with endovascular therapy in acute ischemic stroke (AIS) patients with large vessel occlusion.
Read the detailed description
A prospective, randomized, double-blind, placebo-controlled, multi-center study of Human Urinary Kallidinogenase or Placebo, combined with endovascular therapy for AIS patients with large vessel occlusion.
Approximately 120 eligible subjects will be randomized (1:1) to receive one of the following treatments for 10 days:
- Human Urinary Kallidinogenase combined with endovascular therapy (non-bridged)
- Placebo combined with endovascular therapy (non-bridged) Primary efficacy of Human Urinary Kallidinogenase will be evaluated at 90±7 days.
The safety of Human Urinary Kallidinogenase will be evaluated through 90±7 days.
End of study evaluation will occur at day 90±7 or premature discontinuation.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Experimental: Human Urinary Kallidinogenase, Placebo Comparator: Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Human Urinary KallidinogenaseDrug
Before the first day of endovascular therapy (non-bridging), dissolve Human Urinary Kallidinogenase in 100 mL 0.9% sodium chloride for intravenous injection, for the next 9 days, once a day for a total of 10 days.
Placebo Comparator: PlaceboDrug
Before the first day of endovascular therapy (non-bridging), dissolve placebo in 100 mL 0.9% sodium chloride for intravenous injection, for the next 9 days, once a day for a total of 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Human Urinary Kallidinogenase | Experimental | Not described Receives: Drug: Experimental: Human Urinary Kallidinogenase |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASPECT score evaluated using routine CT
Measured: on day 7 after EVT
Modified Rankin Scale (mRS) score
Measured: on day 90 after EVT
Secondary outcomes (7)
Barthel index
Measured: on day 10 and 90 after EVT
Percentage of TIC ≥ 2b and mRS ≤2
Measured: on day 90 after EVT
Changes of NIH Stroke Scale(NIHSS) score from baseline
Measured: day 1, 4, 7 and 10 after EVT
Changes of vital signs from baseline
Measured: day 1, 4, 7 and 10 after EVT
Changes of blood inflammatory index and vascular endothelial cell growth index from day 1 after EVT
Measured: day 7 after EVT
MRI and / or DWI examined
Measured: within 10 days to determine the infarct volume
Recurrence rate of ischemic stroke
Measured: within 90 days after EVT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start17 Apr 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (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.
- More trials run by Huashan HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Stroke Association
- Responsible party
- Principal investigator, Qiang Dong, Huashan Hospital
- Investigators
- Qiang Dong, M.D., Principal investigator, Huashan HospitalWenjie Cao, M.D., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211712
- Sponsor's protocol ID
- KY2023-707
- Acronym
- HEAL
- Status last verified
- Dec 2024
- First submitted
- 28 Dec 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion: A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Study
- ClinicalTrials.gov ID
- NCT06211712
- Acronym / sponsor ID
- HEAL / KY2023-707
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Stroke Association
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Jan 2024 (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 Human Urinary Kallidinogenase combined with endovascular therapy in acute ischemic stroke (AIS) patients with large vessel occlusion.
Detailed description
A prospective, randomized, double-blind, placebo-controlled, multi-center study of Human Urinary Kallidinogenase or Placebo, combined with endovascular therapy for AIS patients with large vessel occlusion.
Approximately 120 eligible subjects will be randomized (1:1) to receive one of the following treatments for 10 days:
- Human Urinary Kallidinogenase combined with endovascular therapy (non-bridged)
- Placebo combined with endovascular therapy (non-bridged) Primary efficacy of Human Urinary Kallidinogenase will be evaluated at 90±7 days.
The safety of Human Urinary Kallidinogenase will be evaluated through 90±7 days.
End of study evaluation will occur at day 90±7 or premature discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Human Urinary Kallidinogenase | Experimental | Drug: Experimental: Human Urinary Kallidinogenase |
| Placebo | Placebo comparator | Drug: Placebo Comparator: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged).
- Age ≥18 years old.
- The mRS score was 0-1 before onset.
- ASPECT score of infarction on emergency CT ≥7.
- Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery).
Key exclusion criteria (7 listed)
- Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications.
- CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.).
- Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases.
- Taking ACEI antihypertensive drugs regularly and could not stop.
- Participant with major surgery or severe trauma in the past 2 weeks.
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 |
|---|---|---|
| Experimental: Human Urinary KallidinogenaseBefore the first day of endovascular therapy (non-bridging), dissolve Human Urinary Kallidinogenase in 100 mL 0.9% sodium chloride for intravenous injection, for the next 9 days, once a day for a total of 10 days. | Drug | Human Urinary Kallidinogenase |
| Placebo Comparator: PlaceboBefore the first day of endovascular therapy (non-bridging), dissolve placebo in 100 mL 0.9% sodium chloride for intravenous injection, for the next 9 days, once a day for a total of 10 days. | Drug | Placebo |
Primary outcome
ASPECT score evaluated using routine CT
Time frame: on day 7 after EVT
Modified Rankin Scale (mRS) score
Time frame: on day 90 after EVT
7 secondary outcomes
Barthel index
Time frame: on day 10 and 90 after EVT
Percentage of TIC ≥ 2b and mRS ≤2
Time frame: on day 90 after EVT
Changes of NIH Stroke Scale(NIHSS) score from baseline
Time frame: day 1, 4, 7 and 10 after EVT
Changes of vital signs from baseline
Time frame: day 1, 4, 7 and 10 after EVT
Changes of blood inflammatory index and vascular endothelial cell growth index from day 1 after EVT
Time frame: day 7 after EVT
MRI and / or DWI examined
Time frame: within 10 days to determine the infarct volume
Recurrence rate of ischemic stroke
Time frame: within 90 days after EVT
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 4 Dec 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.
Qiang Dong, M.D. principal investigator
Huashan Hospital
Wenjie Cao, M.D. principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Human Urinary Kallidinogenase in people with Acute Ischemic Stroke, run by Huashan Hospital 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 7 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: looking for participants now, as of the sponsor's last update on 4 Dec 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. 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.
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 Qiang Dong, M.D. (13701747065, 13701747065@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASPECT score evaluated using routine CT (time frame: on day 7 after EVT). The study lists 2 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 4 Dec 2024.