Overview

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

Status:
Completed
Trial end date:
2017-01-06
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University Third Hospital
Collaborator:
Peking Union Medical College Hospital
Treatments:
Cinepazide
Criteria
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;