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Clinical Drug Investigation

, Volume 33, Issue 10, pp 755–760 | Cite as

Efficacy and Safety of Mildronate for Acute Ischemic Stroke: A Randomized, Double-Blind, Active-Controlled Phase II Multicenter Trial

  • Yi Zhu
  • Guangyun Zhang
  • Jun Zhao
  • Deshuai Li
  • Xiaodong Yan
  • Juanfang Liu
  • Xuedong Liu
  • Haibo Zhao
  • Jielai Xia
  • Xiao Zhang
  • Zhengyi Li
  • Baorong Zhang
  • Zongcheng Guo
  • Lianyuan Feng
  • Zhaodong Zhang
  • Fang Qu
  • Gang ZhaoEmail author
Original Research Article

Abstract

Background and Objective

Mildronate, an inhibitor of carnitine-dependent metabolism, is considered to be an anti-ischemic drug. This study is designed to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke.

Methods

We performed a randomized, double-blind, multicenter clinical study of mildronate injection for treating acute cerebral infarction. 113 patients in the experimental group received mildronate injection, and 114 patients in the active-control group received cinepazide injection. In addition, both groups were given aspirin as a basic treatment. Modified Rankin Scale (mRS) score was performed at 2 weeks and 3 months after treatment. National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index (BI) score were performed at 2 weeks after treatment, and then vital signs and adverse events were evaluated.

Results

A total of 227 patients were randomized to treatment (n = 113, mildronate; n = 114, active-control). After 3 months, there was no significant difference for the primary endpoint between groups categorized in terms of mRS scores of 0–1 and 0–2 (p = 0.52 and p = 0.07, respectively). There were also no significant differences for the secondary endpoint between groups categorized in terms of NIHSS scores of >5 and >8 (p = 0.98 and p = 0.97, respectively) or BI scores of >75 and >95 (p = 0.49 and p = 0.47, respectively) at 15 days. The incidence of serious adverse events was similar between the two groups.

Conclusion

Mildronate injection is as effective and safe as cinepazide injection in treating acute cerebral infarction.

Keywords

Carnitine Acute Ischemic Stroke Barthel Index Acute Cerebral Infarction Barthel Index Score 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

This study was funded by Ge-Lin Biopharmaceutical Co. Ltd., Shenyang, China. The authors have no potential conflicts of interest that are directly relevant to the content of this study. The Steering Committee for this study consisted of Prof. Su Xiuchu, Prof. Xu Dezhong, Prof. Wu Baoren, and Dr. Fan Fulin. The Safety Board consisted of Prof. Huang Yuangui, Prof. Li Huanzhang, and Prof. Li Kaizong.

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Copyright information

© Springer International Publishing Switzerland 2013

Authors and Affiliations

  • Yi Zhu
    • 1
  • Guangyun Zhang
    • 1
  • Jun Zhao
    • 1
  • Deshuai Li
    • 1
  • Xiaodong Yan
    • 2
  • Juanfang Liu
    • 1
  • Xuedong Liu
    • 1
  • Haibo Zhao
    • 1
  • Jielai Xia
    • 3
  • Xiao Zhang
    • 1
  • Zhengyi Li
    • 4
  • Baorong Zhang
    • 5
  • Zongcheng Guo
    • 6
  • Lianyuan Feng
    • 7
  • Zhaodong Zhang
    • 8
  • Fang Qu
    • 9
  • Gang Zhao
    • 1
    Email author
  1. 1.Department of Neurology, Xijing HospitalThe Fourth Military Medical UniversityXi’anChina
  2. 2.Department of OrthopaedicsTangdu Hospital, Fourth Military Medical UniversityXi’anChina
  3. 3.Department of Health StatisticsFourth Military Medical UniversityXi’anChina
  4. 4.First Affiliated Hospital of Xi’an Jiaotong UniversityXi’anChina
  5. 5.Second Affiliated Hospital, Zhejiang University School of MedicineZhejiangChina
  6. 6.People’s Hospital of Hebei ProvinceHebeiChina
  7. 7.Bethune International Peace Hospital of People’s Liberation ArmyHebeiChina
  8. 8.First Hospital of China Medical UniversityBeijingChina
  9. 9.General Hospital of Shenyang Military RegionShenyangChina

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