Effects of Human Urinary Kallidinogenase on Early Improvement and Functional Outcomes in Acute Ischemic Stroke (TK-SPEED)
1 other identifier
interventional
540
0 countries
N/A
Brief Summary
The primary purpose of this trial is to evaluate the effects of Human Urinary Kallidinogenase on improvement of neurological outcome, and early cerebral perfusion in acute ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2023
CompletedFirst Posted
Study publicly available on registry
November 15, 2023
CompletedStudy Start
First participant enrolled
December 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
December 6, 2023
November 1, 2023
2.7 years
November 8, 2023
November 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of patients with modified Rankin Scale (mRS) 0-2 at day 90
The proportion of patients with modified Rankin Scale (mRS) 0-2 at day 90. mRS scores range from 0 to 6. 0=no symptoms,1 = symptoms without clinically significant disability,2 = slight disability,3 = moderate disability,4 = moderately severe disability,5 = severe disability; and 6 = death.
90 days
Secondary Outcomes (6)
Change of Tmax>6s volume
5 days
Change of rCBF in Tmax>6s area
5 days
Ordinal distribution of modified Rankin Scale (mRS) at day 90
90 days
The proportion of patients with modified Rankin Scale (mRS) 0-1 at day 90
90 days
Change of National Institute of Health stroke Scale (NIHSS) score at day 5 after treatment.
5 days
- +1 more secondary outcomes
Other Outcomes (10)
Change of regional cerebral blood volume (rCBV) in Tmax>6s area
5 days
Change of mean transit time (MTT) in Tmax>6s area
5 days
Change of Tmax>4s volume
5 days
- +7 more other outcomes
Study Arms (2)
Intervention group
EXPERIMENTALIntravenous injections of urinary kallidinogenase (0.15 peptide nucleic acids (PNA) in 0.9% NaCl) intravenous drip quaquedie (QD) for 10 days.
Control group
OTHERConventional therapy of acute ischemic stroke after based on Chinese guidelines.
Interventions
Intravenous injections of urinary kallidinogenase (0.15 peptide nucleic acids (PNA) in 0.9% NaCl) intravenous drip QD for 10 days.
Conventional therapy of acute ischemic stroke after based on Chinese guidelines
Eligibility Criteria
You may qualify if:
- to 80 years of age;
- Diagnosis of anterior circulation acute ischemic stroke;
- Within 48 hours of symptoms onset;
- modified Rankin Scale (mRS) score≤1 before this event;
- ≤NIHSS≤20 at screening;
- The availability of informed consent.
You may not qualify if:
- Patients who have already or are going to receive intravenous thrombolytic/mechanical thrombectomy therapy after onset;
- Patients with severe consciousness disorder, NIHSS 1a consciousness level score≥2;
- Patients with limited limb mobility such as fractures and claudication upon admission;
- Patients who have already or are going to receive Edaravone injection, Edaravone and DeKanol concentrated solution for injection, Butylphthalide and sodium chloride injection or Butylphthalide soft capsules after onset;
- Hypotensive (systolic blood pressure \<90 mmHg or diastolic blood pressure\<60 mmHg) on admission;
- History of severe drug or food allergy, allergy or intolerance to Human Urinary Kallidinogenase;
- Patients who have been on angiotensin-converting enzyme inhibitor (ACEI) drugs and within 5 half-lives (according to the specific drug instructions) before initiate Human Urinary Kallidinogenase treatment;
- Pregnancy, lactation, or planned pregnancy within 90 days;
- Patients with severe renal failure or impairment (eGFR\<30ml/min/1.73m2) at screening;
- Severe hepatic dysfunction, elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (more than 2.5 times of upper limit of normal value), other liver diseases such as 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;
- Heavy drinking in the three months before screening, drinking≥5 standard drinks per day (1 standard drink is equivalent to120ml wine, 360ml beer or 45ml liquor);
- Drug Abuse or addiction in the past year;
- Patients with a malignant tumor, severe systemic diseases, or estimated survival time \<90 days;
- Patients with severe mental disorders or dementia unable to complete the informed consent and follow-up;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jian Wu
Beijing Tsinghua Changgeng Hospital
- STUDY CHAIR
Zunjing Liu
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2023
First Posted
November 15, 2023
Study Start
December 14, 2023
Primary Completion (Estimated)
August 28, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
December 6, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share