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

NCT04951440 | Unknown DMC

• 1 other identifier: D2019009
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Ischemic Stroke

Keywords

Nitroxazine

Outcome Measures

Primary Outcomes (1)

• 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

  On the 14th day of treatment

Secondary Outcomes (1)

• The change of MRS score

  30th day and the 90th day of treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Drug: Nitrate ketone oxazine

Placebo group

PLACEBO COMPARATOR

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.

Drug: Nitrate ketone oxazine

Interventions

Nitrate ketone oxazine DRUG

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.

Intervention group; Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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).

You may not qualify if:

• (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:

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Capital Medical University: collaborator

Study Sites (2)

: Beijing Dan's self technology co., LTD.

Beijing, China

Location

Tiantan Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yongjun Wang

  Tiantan Hospital, Capital Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 6, 2021
• Study Start: June 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)