Status:
COMPLETED
Mildronate for Acute Ischemic Stroke
Lead Sponsor:
Xijing Hospital
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic drug. This study aims to evaluate the efficacy and safety of mildronate injection in treating acute ischemic s...
Detailed Description
A randomized, double-blind, multi-center clinical study was made on mildronate injection for treating acute cerebral infarction. 113 cases in the experimental group were given with mildronate injectio...
Eligibility Criteria
Inclusion
- (i) had a clinical diagnosis of acute ischaemic stroke ,on the first episode within the previous 7 days, and confirmed on CT or MRI brain imaging.(ii) were between 18 to 80 years of age (patients \>= 70 years were not combined with any other poor physical condition except ischaemic stroke )(iii)had a score of 5-22 on the National Institutes of Health Stroke Scale (NIHSS).(iv)had a report that liver and kedney function were less than 1.5 folds of normal value.
Exclusion
- (i) had other intracranial pathologies (e.g. cerebral hemorrhage, tumour, infection), (ii) were pregnant or nursing ;(iii) had a neurological or psychiatric disease ;(iv) had significant drug or alcohol misuse, (v)had been given thrombolytic therapy or medication forbidden by study protocol; (vi)participated in a clinical trial in the past 3 months.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT01831011
Start Date
July 1 2008
End Date
April 1 2010
Last Update
April 12 2013
Active Locations (1)
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1
the Department of Neurology
Xi’an, Shanxi, China, 710032