NCT06137300Not yet recruiting
Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke
Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke:a Multicentre, Prospective, Randomised, Open-label, Blinded-Endpoint Trial
Source: ClinicalTrials.gov · Last updated 28 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 986 (estimated)
- First submitted
- 14 Nov 2023
- Start date
- 15 Mar 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Yi Yang
- Diseases
- Stroke
- NCT number
- NCT06137300
What you commit to
- Study type: Interventional
- Planned participants: 986
- From 15 Mar 2024 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy);
- Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly;
- Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment;
Other illness
- 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;
- Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.);
- Other conditions considered by the investigator to be inappropriate for enrollment.
Lab values
- Liver dysfunction (ALT/AST \>1.5 × upper limit of normal \[ULN\]), renal dysfunction (Cr \>1 × ULN);
- Coagulopathy (prolonged INR (\>1.5) or prolonged APTT (\>2 folds);
Other
- Transient ischemic attack;
- Severe disturbance of consciousness:GCS ≤8;
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.