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Mildronate for Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT01831011
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : April 12, 2013
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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 stroke.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: mildronate injection Drug: cinepazide maleate injection Drug: aspirin Phase 2

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 injection, while 114 cases in the active-control group were given with cinepazide maleate injection. In addition, both groups were given aspirin as basic treatments. Modified Rankin Scale (mRS) score at 2 weeks and 3 months, National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index score at 2 weeks after treatment, vital signs and adverse events were evaluated.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Mildronate for Acute Ischemic Stroke: a Randomized, Double-blind, Active-controlled Phase II Multicenter Trial
Study Start Date : July 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: mildronate
infusion of mildronate
Drug: mildronate injection
Other Name: infusion of mildronate infusion of mildronate(500mg) once a day and for 14 da

Drug: aspirin
Other Name: infusion of aspirin (100mg) once a day for days

Active Comparator: cinepazide maleate
infusion of cinepazide maleate
Drug: cinepazide maleate injection
Other Name: infusion of plabcebo once a day and for 14 days

Drug: aspirin
Other Name: infusion of aspirin (100mg) once a day for days




Primary Outcome Measures :
  1. the modified Rankin scale [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. NIHSS scores [ Time Frame: 15 days ]
  2. the Barthel index [ Time Frame: 15 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (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 Criteria:

  • (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831011


Locations
China, Shanxi
the Department of Neurology
Xi an, Shanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Director: Gang Zhao, MD the Department of Neurology , Xijing Hospital
Principal Investigator: Guang Yun Zhang, MD the Department of Neurology , Xijing Hospital
Principal Investigator: Yi Zhu, MD the Department of Neurology , Xijing Hospital

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01831011     History of Changes
Other Study ID Numbers: xijing-008
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: April 2013

Keywords provided by Xijing Hospital:
randomized trial
acute ischemic stroke
mildronate

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Aspirin
Maleic acid
3-(2,2,2-trimethylhydrazine)propionate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics