Clinical Study of Cinepazide Maleate Injection in the Treatment of Acute Ischemic Stroke

Cinepazide Maleate Injection in the Treatment of Acute Ischemic Stroke A Blind, Multicenter, Placebo-controlled Clinical Confirmatory Study.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel controlled, post marketing confirmatory clinical trial in Chinese patients with acute ischemic stroke. Objective to evaluate the efficacy and safety of cinepazide maleate injection compared with placebo in the treatment of patients with acute ischemic stroke.

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Drug: Cinepazide Maleate; Other: Placebo

Detailed Description

The target population of this study is patients with acute ischemic stroke within 48 hours. All potential participants must provide informed consent, and those who provide informed consent will enter the screening (- 48 ~ 0h), and the screening qualification will be evaluated according to the inclusion criteria. The eligible subjects will enter the treatment period (day 1-14) and will be randomly assigned to the experimental group (cinepazide maleate injection group) or the control group (placebo group).

During the treatment period, all subjects will receive cinepazide maleate injection or placebo by intravenous drip at the rate of 100ml / h, once a day for 14 consecutive days. During the treatment, all subjects need to receive basic treatment: citicoline sodium injection 0.5g, dissolved in 5% glucose injection or normal saline 250ml, intravenous drip slowly, once a day, continuous administration for 10 days. According to the Chinese guidelines for the diagnosis and treatment of acute ischemic stroke (2014), the patients were given antihypertensive, hypoglycemic, lipid-lowering, anticoagulant or mannitol. All subjects were not allowed to receive interventional therapy, thrombolysis (such as rtPA and urokinase), defibrillator, any platelet inhibitor except aspirin and clopidogrel, other cerebrovascular dilators (such as cinnarizine, flunarizine, nicardipine and nimodipine), other neuroprotective agents (except citicoline) during the whole trial period After the end of the treatment period (the 14th day), the subjects will enter the follow-up period (the 15th-90th day).

During the follow-up period, subjects need to be followed up twice (30th day) ± 2 days, 90th day ± 3 days).

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. 18-80 years old (contains 18 and 80 years), with no limit for both sexes; 2. Acute internal carotid artery was diagnosed according to the Chinese guidelines for the diagnosis and treatment of acute ischemic stroke (2014) Cerebral infarction of the arterial system (anterior circulation), well after first onset or last onset (MRS score 0-1) patients; 3. Onset ≤ 48 hours (onset to randomization within 48 hours); 4. 5 points ≤ NIHSS ≤ 25 at presentation; 5. Informed consent was signed by the patients or their legal surrogates.

Exclusion Criteria:

• 1. Patients with recurrent cerebral infarction with pre Mrs score ≥ 2 at this time; 2. Cranial CT suggestive of intracranial haemorrhagic disease (e.g Intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.); 3. Cerebral infarction with impaired consciousness (NIHSS score of 1A items ≥ 1), transient ischemic attack Zuo, cerebral arteritis, brain tumor, brain trauma, intracranial infection, cerebral parasite disease patients; 4. Patients who have undergone or require interventional, thrombolytic, and defibrillation therapy after this episode; 5. History or evidence of any one of the following diseases during the screening period:

  • poorly controlled hypertension with systolic blood pressure ≥ 200mmhg or diastolic blood pressure ≥ 110mmhg during screening period;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group (cinnarizide maleate injection group)	Drug: Cinepazide Maleate; The experimental group: guipiprazitel maleate injection (klingo): 320mg (4), dissolved in 500ml of normal saline, and injected in a medium vein at a rate of 100ml/h, once a day, and administered for 14 days.
Placebo Comparator: control group (placebo group)	Other: Placebo; Placebo: 4 pieces, dissolved in normal saline 500ml, intravenous drip, the speed is 100ml / h, once a day, continuous administration for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
score of modified Rankin Scale(MRS)	proportion of subjects with a modified Rankin Scale (MRS) ≤ 2	at day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ability of daily life	the score of Barth index(BI)	at day 90

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2016
• Primary Completion (Actual): January 6, 2017
• Study Completion (Actual): January 6, 2017

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia; Vasodilator Agents; Cinepazide
• Other Study ID Numbers: D2016058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No