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Study on the Effectiveness and Safety of Nitrone for Injection in Patients With Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nitrate ketone oxazine
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Nitroxazine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • (1) the age 18 to 65 years of age, gender not limited (including 18 and 65 years old) :(2) according to the Chinese guide of diagnosis and treatment of acute ischemic stroke (2018) with a diagnosis of acute ischemic strokeThe lender;(3) from the "look" normal time to start infusion for lamictal nitrate or placebo < 6 hours, to wake up or stroke due to accurately obtain aphasia, disturbance of consciousness and other symptom onset time, shall be made in patients with the last performance of normal time I;(4) after the first or the last disease incidence after the more good (mkS score 0-1) disease patients again;(5) at the four points < NIHISS score < 24 points;(6) from beginning to the last delivery signed informed consent is willing to take effective contraceptive measures within 6 months after:Understand and abide by the research process and voluntary participation, and sign the informed consent form (informed consent signed by the person or legal representative voluntary).

Exclusion Criteria:

  • (1) the patients with recurrent cerebral infarction incidence before mRS score > 1;(2) unconsciousness (NIHSS score la 22 points);(3) neural imaging examination (CT/MRI) suggests intracerebral hemorrhagic disease (such as: hemorrhagic cerebral apoplexy, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.)(4) imaging examination showed middle cerebral artery infarction area > one-third, or ASPECT score < 7 points:(5) transient ischemic attack (TIA) :(6) to prepare or have lines endovascular treatment of patients;(7), severe renal insufficiency: creatinine clearance < 30 mL/min (Cockcroft - Gault formula), blood urea nitrogen and/or muscle > 1.5 times the upper limit of normal value, or other serious kidney function is not complete disease known;Severe liver function damage (8) : ALT, AST > 1.5 times the upper limit of normal value, or other known liver diseases such as acute or chronic hepatitis, liver cirrhosis, etc;(9) hospital routine blood tip: white blood cells < normal lower limit; Hemoglobin < normal lower limit; Hospital to check blood sugar < 2.8 tendency for L, or > 16.8 mmo / /; Temperature > 38 c; Other laboratory examination with clinical significance is unusual, and the researchers of decision should not be set;(10) are poorly controlled hypertension, systolic blood pressure > 220 MMHG 2 120 MMHG and/or diastolic blood pressure:(11) heart rate < 40 times/min and/or heart rate > 120 times/min: nearly six months or line of interventional therapy of acute myocardial infarction (ami), patients with heart failure (in the patients with NYHA class for 111-1 v);(12) in patients with epilepsy: merging other patients with mental illness to cooperation or unwilling to cooperation; Patients with dementia.(13) of malignant tumor, blood, digestive serious illness, or other system.(14) on experimental drug or similar components or materials used for imaging examination allergies;(15) blood positie pregnancy, pregnancy and lactation women:

Sites / Locations

  • : Beijing Dan's self technology co., LTD.
  • Tiantan Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Placebo group

Arm Description

Intervention group: 30min intravenous point. Infusion of 1400 mg of tetranitrone was given to bed I with a dose of 100ml, twice a day, with an interval of 12 hours, and continued administration for 7 days, that is, a total of about 14 times. version

Placebo group: 30 minutes to earn pulse, I, 1, and dripping Yunmi gave 100mL placebo (sodium chloride injection). It is administered twice a day for 1 to 2 hours, and the pattern is transferred to about 7 people, that is, about 14 times in total.

Outcomes

Primary Outcome Measures

Percentage of patients with NIHSS ≤1 or a reduction of 4 or more points from baseline
Percentage of patients with NIHSS ≤1 or a reduction of 4 or more points from baseline at day 14 of treatment

Secondary Outcome Measures

The change of MRS score
The change of MRS score (change detection and rate of change) at the 30th day and the 90th day of treatment compared with the plexus line.

Full Information

First Posted
June 27, 2021
Last Updated
June 27, 2021
Sponsor
Peking University Third Hospital
Collaborators
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04951440
Brief Title
Study on the Effectiveness and Safety of Nitrone for Injection in Patients With Acute Ischemic Stroke
Official Title
Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Trial to Evaluate the Effectiveness and Safety of Nitrone for Injection in Patients With Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of the study: To evaluate the effect of nitrosone 1 special for patients with acute ischemic cerebral stroke. The secondary purpose of the study: To evaluate the effectiveness of the injection of nitrosone I. T for loyal patients with acute ischemic stroke All women think.
Detailed Description
The main purpose of the study: To evaluate the effect of nitrosone 1 special for patients with acute ischemic cerebral stroke. The secondary purpose of the study: To evaluate the effectiveness of the injection of nitrosone I. T for loyal patients with acute ischemic stroke All women think. This experiment adopts randomized, double-blind, placebo-controlled parallel design. In patients with acute, ischemic cerebral rate as the research object, after selected exclusion standard screening, if doesn't fit or don't agree with thrombolysis subjects, giving from connect to test a drug or a placebo treatment, if appropriate and agreed to thrombolysis of the subjects with an experimental drug or placebo after thrombolysis treatment.Intervention group: 30) min uniform given 1400 mg intravenous drip injection with ketone wordy, nitrate dosing volume 100 ml. Day delivery, two intervals of 12 h, for seven days in a row, namely to 14 times in total.The placebo group: 30 min to 100 ml placebo at a constant speed intravenous drip (sodium chloride injection), dosing W times a day, 12 h, for seven days in a row, namely to 14 times in total.During treatment, participants in the group after injection with nitrate ketone oxazine (giving injections with nitrate ketone oxazine time window < 6 h, that is, from "the last look normal time" to start infusion nitrate obviously time) or placebo and other foundation treatment. Record for the first time to give the time of nitrate ketone oxazine or placebo for injection, lie between 8 and 12 h 2 times to medicine."After 12 h dosing interval, until finish to 14 times (for convenient subjects out of the hospital and acceptable to 13).Allow this study drug and placebo and thrombolysis drug dosing dual channel at the same timeStop to test drug or placebo, in the group of 8 days, 14 days, 30 days, the 90th day to evaluate curative effect, respectively.In the I the ili is not ah into subgroups according to try tii statistical treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Nitroxazine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention group: 30min intravenous point. Infusion of 1400 mg of tetranitrone was given to bed I with a dose of 100ml, twice a day, with an interval of 12 hours, and continued administration for 7 days, that is, a total of about 14 times. version
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo group: 30 minutes to earn pulse, I, 1, and dripping Yunmi gave 100mL placebo (sodium chloride injection). It is administered twice a day for 1 to 2 hours, and the pattern is transferred to about 7 people, that is, about 14 times in total.
Intervention Type
Drug
Intervention Name(s)
Nitrate ketone oxazine
Intervention Description
Intervention group: 30min intravenous point. Drop qiu was given 1400 mg of injected sichuan nitrone I bed, and the drug was given 100 mL at day F Set 12 h, and at odds with another 7 days, that is, about 14 times in total.
Primary Outcome Measure Information:
Title
Percentage of patients with NIHSS ≤1 or a reduction of 4 or more points from baseline
Description
Percentage of patients with NIHSS ≤1 or a reduction of 4 or more points from baseline at day 14 of treatment
Time Frame
On the 14th day of treatment
Secondary Outcome Measure Information:
Title
The change of MRS score
Description
The change of MRS score (change detection and rate of change) at the 30th day and the 90th day of treatment compared with the plexus line.
Time Frame
30th day and the 90th day of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (1) the age 18 to 65 years of age, gender not limited (including 18 and 65 years old) :(2) according to the Chinese guide of diagnosis and treatment of acute ischemic stroke (2018) with a diagnosis of acute ischemic strokeThe lender;(3) from the "look" normal time to start infusion for lamictal nitrate or placebo < 6 hours, to wake up or stroke due to accurately obtain aphasia, disturbance of consciousness and other symptom onset time, shall be made in patients with the last performance of normal time I;(4) after the first or the last disease incidence after the more good (mkS score 0-1) disease patients again;(5) at the four points < NIHISS score < 24 points;(6) from beginning to the last delivery signed informed consent is willing to take effective contraceptive measures within 6 months after:Understand and abide by the research process and voluntary participation, and sign the informed consent form (informed consent signed by the person or legal representative voluntary). Exclusion Criteria: (1) the patients with recurrent cerebral infarction incidence before mRS score > 1;(2) unconsciousness (NIHSS score la 22 points);(3) neural imaging examination (CT/MRI) suggests intracerebral hemorrhagic disease (such as: hemorrhagic cerebral apoplexy, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.)(4) imaging examination showed middle cerebral artery infarction area > one-third, or ASPECT score < 7 points:(5) transient ischemic attack (TIA) :(6) to prepare or have lines endovascular treatment of patients;(7), severe renal insufficiency: creatinine clearance < 30 mL/min (Cockcroft - Gault formula), blood urea nitrogen and/or muscle > 1.5 times the upper limit of normal value, or other serious kidney function is not complete disease known;Severe liver function damage (8) : ALT, AST > 1.5 times the upper limit of normal value, or other known liver diseases such as acute or chronic hepatitis, liver cirrhosis, etc;(9) hospital routine blood tip: white blood cells < normal lower limit; Hemoglobin < normal lower limit; Hospital to check blood sugar < 2.8 tendency for L, or > 16.8 mmo / /; Temperature > 38 c; Other laboratory examination with clinical significance is unusual, and the researchers of decision should not be set;(10) are poorly controlled hypertension, systolic blood pressure > 220 MMHG 2 120 MMHG and/or diastolic blood pressure:(11) heart rate < 40 times/min and/or heart rate > 120 times/min: nearly six months or line of interventional therapy of acute myocardial infarction (ami), patients with heart failure (in the patients with NYHA class for 111-1 v);(12) in patients with epilepsy: merging other patients with mental illness to cooperation or unwilling to cooperation; Patients with dementia.(13) of malignant tumor, blood, digestive serious illness, or other system.(14) on experimental drug or similar components or materials used for imaging examination allergies;(15) blood positie pregnancy, pregnancy and lactation women:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang
Organizational Affiliation
Capital Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
: Beijing Dan's self technology co., LTD.
City
Beijing
Country
China
Facility Name
Tiantan Hospital, Capital Medical University
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Study on the Effectiveness and Safety of Nitrone for Injection in Patients With Acute Ischemic Stroke

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