Urinary Kallidinogenase Tested in Stroke Patients With Type 2 Diabetes
Tests urinary kallidinogenase against placebo in adults with acute ischemic stroke and diabetes.
Key facts
- Who runs it
- First Affiliated Hospital, Sun Yat-Sen University
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- Efficacy and Safety of Urinary Kallidinogenase in the Treatment of Acute Ischemic Stroke Combined With Type 2 Diabetes Mellitus
- Status
- Not yet recruiting
- People taking part
- 630 people, planned
- Started
- 1 Jan 2024
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Urinary Kallidinogenase for injection
- Placebo
- Record updated
- 16 October 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 who had a recent acute ischemic stroke and also have type 2 diabetes.
- Age
- 18 to 80 years old.
- Sex
- Men and women can both join.
- Disease stage
- Acute ischemic stroke affecting the front part of the brain's blood supply (complete or partial anterior circulation infarction), less than 48 hours from stroke to admission, with an NIHSS score of 6 to 20. Type 2 diabetes must be confirmed by medical history.
- Earlier treatment
- First stroke, or an earlier stroke with mRS of 1 or less before this one. People who had or are about to have clot-busting treatment or an intravascular procedure after this stroke cannot join. Certain stroke medicines (Edaravone, Butylphthalide) or Chinese patent injections for brain blood flow used after onset also rule people out.
Main reasons for not taking part
- Bleeding in the brain seen on imaging
- Severe disturbance of consciousness (NIHSS 1a score of 2 or more)
- Low blood pressure on admission (under 90/60mmHg) or severe kidney or liver problems
- Recent serious heart problems, such as heart failure, unstable angina or heart attack within 6 months
- Pregnant or breastfeeding, or planning pregnancy within 90 days
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- 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 take part
- 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 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
- Participated in any interventional drug or device clinical trials within 3 months prior to screening
- 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
- Chinese patent medicine injection for improving cerebral blood circulation has been applied after the onset of this disease (see 8.4.2 for details)
- Have a history of severe food or drug allergy, or have been allergic to or intolerant of Eurecline injection
- 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
- 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
- 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
- Severe disturbance of consciousness: NIHSS 1a consciousness level score ≥2
- Patients with fracture, claudication and other factors affecting functional outcome score upon admission
- Patients with hypotension (blood pressure less than 90/60mmHg) upon admission
- Patients who are pregnant or breastfeeding and who plan to become pregnant within 90 days
- Patients deemed unsuitable for study participation by the investigator
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Jinsheng ZengNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Urinary Kallidinogenase for injectionTreatment being tested
Patients in this arm will be given urinary kallidinogenase for injection, 0.15 peptide nucleic acids(PNA), once a day for 10 days
- PlaceboPlacebo, for comparison
An inactive substance identical in appearance to the urinary kallidinogenase for injection, once a day for 10 days
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Urinary Kallidinogenase Tested in Stroke Patients With Type 2 DiabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06085378, who can take part
- Record updated
- 16 October 2023