The Study to Reevaluate the Safety and Efficacy of Human Urinary Kallikrein
1 other identifier
interventional
2,186
1 country
7
Brief Summary
In order to reevaluate safety and efficacy of human urinary kallikrein in treating acute cerebral infarction ,a multi-center, open label , single group study was designed. Expect to enroll 60 sites and 2186 subjects. Subjects will receive kallikrein treatment according to real clinical practice (suggest above 14days treatment) and 90 days follow up
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2015
Typical duration for phase_4
7 active sites
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
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 10, 2015
CompletedFirst Posted
Study publicly available on registry
September 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedJanuary 17, 2018
January 1, 2018
3.3 years
September 10, 2015
January 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events
From enrolled to the day 90
Secondary Outcomes (6)
Cerebral infarction on the National Institute of Health stroke scale
The day 8,15 and 22 after enrolled
Recurrence rate of acute cerebral infarction
From enrolled to the day 90
Activities of daily living on the Barthel Index
The day 15,22 and 90 after enrolled
Patients body status on the Modified Rankin Scale
The day 15, 22 and 90 after enrolled
EQ-5D-3L score
The day 15, 22 and 90 after enrolled
- +1 more secondary outcomes
Study Arms (1)
kallikrein group
EXPERIMENTALSubjects receive kallikrein treatment according to real clinical practice (suggest above 14days treatment),0.15 peptide nucleic acids(PNA), once a day.
Interventions
Eligibility Criteria
You may qualify if:
- Acute anterior circulation cerebral infarction diagnosed ≤ 48h;
- First time diagnosed or have history of acute anterior circulation cerebral infarction without serious sequelae(mRS=0-2);
- Age from 18 to 80 years old;
- National Institute of Health stroke scale(NIHSS) from 6 to 25;
- Have provided signed written informed consent from the patient or the patient's legal representative.
You may not qualify if:
- Brain CT shows cerebral hemorrhage disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.
- Transient ischemic attack(TIA);
- Serious disturbance of consciousness: Glasgow Coma ScaleGCS（GCS）≤8;
- Combined angiotensin-converting enzyme inhibitor(ACEI) less than 5 half-time(according to its instruction), or need to be treated with ACEI;
- Cases treated with thrombolysis / stent surgery or expected to be treated with thrombolysis / interventional therapy / stent surgery.
- subjects with bleeding disorders at Past or present, laboratory tests: INR \> 1.5 or APTT \> 2 times;
- subjects with abnormal liver function (ALT/AST \> 1.5 \* ULN) and abnormal renal function (Cr\> normal upper limit);
- subjects with history of epilepsy or other serious systemic disease before onset of AIS refused by PI to enroll ;
- subjects with cardiogenic stroke or cardiogenic stroke related high-risk factors identified by PI, such as atrial fibrillation, echocardiography or Mural thrombus etc;
- subjects diagnosised any malignancy (except basal cell carcinoma) within 5 years prior to the start of the study;
- subjects with severe dementia or can't cooperate to evaluate identified by PI;
- suffering from severe hypertension and failed to control :systolic blood pressure ≥200mmHg (26.6kPa) or diastolic blood pressure ≥110mmHg (14.6kPa); hypotension: systolic blood pressure\< 90mmHg and/or diastolic blood pressure\< 60mmHg
- subjects be allergic or intolerant to kallikrein at past;
- subjects be pregnant/lactating or possibly and planned pregnant;
- subjects be unsuitable for this clinical study identified by PI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
NO.2 Hospital XiaMen
Xiamen, Fujian, 361000, China
HanDan Central Hospital
Handan, Hebei, 056001, China
Harrison International Peace Hospital
Hengshui, Hebei, 053000, China
Chenzhou NO.1 People's Hospital
Chenzhou, Hunan, 423000, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000, China
The Fourth Affiliated hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000, China
Related Publications (1)
Ni J, Qu J, Yao M, Zhang Z, Zhong X, Cui L; RESK investigators. Re-evaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK): Protocol for an Open-Label, Single-Arm, Multicenter Phase IV Trial for the Treatment of Acute Ischemic Stroke in Chinese Patients. Transl Stroke Res. 2017 Aug;8(4):341-346. doi: 10.1007/s12975-017-0527-5. Epub 2017 Mar 6.
PMID: 28265861DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liying Cui, Doctor
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2015
First Posted
September 29, 2015
Study Start
August 1, 2015
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
January 17, 2018
Record last verified: 2018-01