Acute Ischemic StrokeTK-SEEKNCT06085378
Efficacy and Safety of Urinary Kallidinogenase in the Treatment of Acute Ischemic Stroke Combined With Type 2 Diabetes Mellitus
A study testing Urinary Kallidinogenase for injection in people with Acute Ischemic Stroke and Type 2 Diabetes, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blind, placebo parallel control study, aim to evaluate the efficacy and safety of human urinary kallidinogenase in the treatment of acute ischemic stroke with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke, Type 2 Diabetes
- What is being tested?
- Urinary Kallidinogenase for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 630 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and ≤80 years old;
- Patients with acute ischemic stroke diagnosed with complete anterior circulation infarction (TACI) and partial anterior circulation infarction (PACI) according to Oxfordshire Community Stroke Project classification (OCSP), see Appendix 6;
- Refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition), have been diagnosed with type 2 diabetes (need to have a medical history to confirm), see Appendix 7;
- The time from the occurrence of the stroke to the time of admission is less than 48h. If the exact time of onset is unknown, the time of onset of the patient is defined as "the time that finally seems normal";
- First-ever ischemic stroke or have history of ischemic stroke but mRS≤1 before onset;
- 6≤NIHSS≤20;
- Have provided signed written informed consent from the patient or the patient's legal representative
Who cannot join
- Acute intracranial hemorrhagic diseases confirmed by imaging: parenchymal hemorrhage, epidural hematoma, subdural hematoma, ventricle hemorrhage, subarachnoid hemorrhage, etc.
- Patients who are ready to undergo or have undergone intravascular interventional therapy after the onset of the disease;
- Patients who are ready to undergo or have undergone intravenous thrombolytic therapy after the onset of the disease;
- Severe disturbance of consciousness: NIHSS 1a consciousness level score ≥2;
- Patients with fracture, claudication and other factors affecting functional outcome score upon admission;
- After the onset of the disease, Edaravone injection, Edaravone and Dexborneol concentrated solution for injection, Butylphthalide and sodium chloride injection or Butylphthalide soft capsules have been used;
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- Chinese patent medicine injection for improving cerebral blood circulation has been applied after the onset of this disease (see 8.4.2 for details);
- Patients with hypotension (blood pressure less than 90/60mmHg) upon admission;
- Have a history of severe food or drug allergy, or have been allergic to or intolerant of Eurecline injection;
- Eurecline for injection has used angiotensin-converting enzyme inhibitor (ACEI) drugs before taking the drug and has not exceeded 5 half-lives (according to the specific drug instructions);
- Patients who are pregnant or breastfeeding and who plan to become pregnant within 90 days;
- Renal failure or severe renal impairment at the time of screening (creatinine clearance < 30ml/min);
- Liver function impairment: alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2.5 times the upper limit of normal, or other known serious liver diseases such as active infection of acute and chronic hepatitis, cirrhosis, etc.;
- Patients with heart failure (NYHA class III or IV), unstable angina pectoris, acute myocardial infarction, severe arrhythmia, and degree II and III cardiac conduction obstruction within 6 months prior to randomization;
- Those who meet the heavy drinking standard in the three months before the screening period, that is, drinking ≥5 standard drinks per day (1 standard drink is equivalent to 120ml wine, 360ml beer or 45ml liquor);
- Patients who have abused or become addicted to drugs (narcotics, drugs) in the past year;
- Patients with malignant tumors or severe systemic diseases with an expected survival of less than 90 days;
- Patients with serious mental disorders or dementia who cannot cooperate to complete informed consent and follow-up;
- Participated in any interventional drug or device clinical trials within 3 months prior to screening;
- Patients deemed unsuitable for study participation by the investigator;
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
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Jinsheng Zeng, +8613322800657, zengjs@pub.guangzhou.gd.cn
Jian Zhang, +8613560451639, zhjian55@mail.sysu.edu.cn
About this study
Official title: Efficacy and Safety of Urinary Kallidinogenase in the Treatment of Acute Ischemic Stroke Combined With Type 2 Diabetes Mellitus (TK-SEEK): a Prospective, Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Study
This study is a multicenter, randomized, double-blind, placebo parallel control study, aim to evaluate the efficacy and safety of human urinary kallidinogenase in the treatment of acute ischemic stroke with type 2 diabetes.
Read the detailed description
The study process lasts for a total of 90 days, including the screening period, intervention period, and follow-up period. During the intervention period, the experimental group is treated with Urinary Kallidinogenase, while the control group is treated with placebo for 10 days. Both groups receive routine clinical treatment. All patients are followed up until the 90th day after stroke. The sample size of the study is 630 patients. The ratio of the experimental group to the control group is 1:1.
- Conditions
- Acute Ischemic Stroke, Type 2 Diabetes
- Being tested
- Urinary Kallidinogenase for injection, Placebo
- Medical subject headings
- Ischemic Stroke, Diabetes Mellitus, Type 2
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 KLK、HUK
The 0.15 peptide nucleic acids(PNA) unit of Eurecrine for injection was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day. The solvent can be increased and/or slowed down according to the patient's condition for 10 consecutive days, while receiving clinical routine treatment for 10 days
PlaceboOther
The 0.15 peptide nucleic acids(PNA) unit of placebo was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day. The solvent can be increased and/or slowed down according to the patient's condition for 10 consecutive days, while receiving clinical routine treatment for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Urinary Kallidinogenase for injection | Experimental | Patients in this arm will be given urinary kallidinogenase for injection, 0.15 peptide nucleic acids(PNA), once a day for 10 days Receives: Drug: Urinary Kallidinogenase for injection |
| Placebo | Placebo comparator | An inactive substance identical in appearance to the urinary kallidinogenase for injection, once a day for 10 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days
The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days
Measured: 90±7 days
Secondary outcomes (6)
The proportion of patients with modified rankin scale (mRS) 0-3 scores at 90±7 days
The proportion of patients with modified rankin scale (mRS) 0-3 scores at 90±7 days
Measured: 90±7 days
Distribution of modified rankin scale (mRS) at 90±7 days
Distribution of modified rankin scale (mRS) at 90±7 days
Measured: 90±7 days
Changes of NIHSS from baseline to 10 days
Changes of NIHSS from baseline to 10 days
Measured: from baseline to day 10
Changes of Barthel index from baseline to 90±7 days
Changes of Barthel index from baseline to 90±7 days
Measured: from baseline to day 90±7
Changes of mini-mental state examination (MMSE) from baseline to 90±7 days
Changes of mini-mental state examination (MMSE) from baseline to 90±7 days
Measured: from baseline to day 90±7
Changes of Montreal cognitive assessment (MoCA) from baseline to 90±7 days
Changes of Montreal cognitive assessment (MoCA) from baseline to 90±7 days
Measured: from baseline to day 90±7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinsheng Zeng, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jinsheng Zeng, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085378
- Sponsor's protocol ID
- IIT-2023-509
- Acronym
- TK-SEEK
- Status last verified
- Oct 2023
- First submitted
- 7 Sep 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Urinary Kallidinogenase in the Treatment of Acute Ischemic Stroke Combined With Type 2 Diabetes Mellitus (TK-SEEK): a Prospective, Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Study
- ClinicalTrials.gov ID
- NCT06085378
- Acronym / sponsor ID
- TK-SEEK / IIT-2023-509
- Conditions
- Acute Ischemic Stroke, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Oct 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.
This study is a multicenter, randomized, double-blind, placebo parallel control study, aim to evaluate the efficacy and safety of human urinary kallidinogenase in the treatment of acute ischemic stroke with type 2 diabetes.
Detailed description
The study process lasts for a total of 90 days, including the screening period, intervention period, and follow-up period. During the intervention period, the experimental group is treated with Urinary Kallidinogenase, while the control group is treated with placebo for 10 days. Both groups receive routine clinical treatment. All patients are followed up until the 90th day after stroke. The sample size of the study is 630 patients. The ratio of the experimental group to the control group is 1:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary Kallidinogenase for injection | Experimental | Drug: Urinary Kallidinogenase for injectionPatients in this arm will be given urinary kallidinogenase for injection, 0.15 peptide nucleic acids(PNA), once a day for 10 days |
| Placebo | Placebo comparator | Other: PlaceboAn inactive substance identical in appearance to the urinary kallidinogenase for injection, once a day for 10 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years old and ≤80 years old;
- Patients with acute ischemic stroke diagnosed with complete anterior circulation infarction (TACI) and partial anterior circulation infarction (PACI) according to Oxfordshire Community Stroke Project classification (OCSP), see Appendix 6;
- Refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition), have been diagnosed with type 2 diabetes (need to have a medical history to confirm), see Appendix 7;
- The time from the occurrence of the stroke to the time of admission is less than 48h. If the exact time of onset is unknown, the time of onset of the patient is defined as "the time that finally seems normal";
- First-ever ischemic stroke or have history of ischemic stroke but mRS≤1 before onset;
Key exclusion criteria (20 listed)
- Acute intracranial hemorrhagic diseases confirmed by imaging: parenchymal hemorrhage, epidural hematoma, subdural hematoma, ventricle hemorrhage, subarachnoid hemorrhage, etc.
- Patients who are ready to undergo or have undergone intravascular interventional therapy after the onset of the disease;
- Patients who are ready to undergo or have undergone intravenous thrombolytic therapy after the onset of the disease;
- Severe disturbance of consciousness: NIHSS 1a consciousness level score ≥2;
- Patients with fracture, claudication and other factors affecting functional outcome score upon admission;
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: KLK、HUKThe 0.15 peptide nucleic acids(PNA) unit of Eurecrine for injection was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day. The solvent can be increased and/or slowed down according to the patient's condition for 10 consecutive days, while receiving clinical routine treatment for 10 days | Drug | Urinary Kallidinogenase for injection |
| PlaceboThe 0.15 peptide nucleic acids(PNA) unit of placebo was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day. The solvent can be increased and/or slowed down according to the patient's condition for 10 consecutive days, while receiving clinical routine treatment for 10 days. | Other | Placebo |
Primary outcome
The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days
Time frame: 90±7 days
The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days
6 secondary outcomes
The proportion of patients with modified rankin scale (mRS) 0-3 scores at 90±7 days
Time frame: 90±7 days
Distribution of modified rankin scale (mRS) at 90±7 days
Time frame: 90±7 days
Changes of NIHSS from baseline to 10 days
Time frame: from baseline to day 10
Changes of Barthel index from baseline to 90±7 days
Time frame: from baseline to day 90±7
Changes of mini-mental state examination (MMSE) from baseline to 90±7 days
Time frame: from baseline to day 90±7
Changes of Montreal cognitive assessment (MoCA) from baseline to 90±7 days
Time frame: from baseline to day 90±7
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 16 Oct 2023.
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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.
Jinsheng Zeng principal investigator
First Affiliated Hospital, Sun Yat-Sen 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 in people with Acute Ischemic Stroke and Type 2 Diabetes, run by First Affiliated Hospital, Sun Yat-Sen University 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 20 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 16 Oct 2023. 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 Jinsheng Zeng (+8613322800657, zengjs@pub.guangzhou.gd.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days (time frame: 90±7 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 16 Oct 2023.