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

NCT04951232 | Completed DMC

• 1 other identifier: D2016058
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• score of modified Rankin Scale(MRS)

  proportion of subjects with a modified Rankin Scale (MRS) ≤ 2

  at day 90

Secondary Outcomes (1)

• ability of daily life

  at day 90

Study Arms (2)

Test group (cinnarizide maleate injection group)

EXPERIMENTAL

Drug: Cinepazide Maleate

control group (placebo group)

PLACEBO COMPARATOR

Other: Placebo

Interventions

Cinepazide Maleate DRUG

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.

Test group (cinnarizide maleate injection group)

Placebo OTHER

Placebo: 4 pieces, dissolved in normal saline 500ml, intravenous drip, the speed is 100ml / h, once a day, continuous administration for 14 days

control group (placebo group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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;

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

cinepazide

Condition Hierarchy (Ancestors)

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

Study Officials

• Dongsheng Fan

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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: July 4, 2016
• Primary Completion: January 6, 2017
• Study Completion: January 6, 2017
• Last Updated: July 6, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)