Efficacy and Safety of Mildronate for Acute Ischemic Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01800357
First received: February 25, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted

February 25, 2013
February 25, 2013
January 2013
June 2014   (final data collection date for primary outcome measure)
the modified Rankin scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • NIHSS scores [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • NIHSS scores [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • the Barthel index [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • the Barthel index [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Mildronate for Acute Ischemic Stroke
Efficacy and Safety of Mildronate for Acute Ischemic Stroke: Study Protocol for a Randomized, Double-blind, Placebo-controlled Phase II Multicenter Trial

This study seeks to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke

a randomized, double-blind, placebo-controlled phase II multicenter trial is conducted to evaluate the efficacy and safety of mildronate injection in patients with acute ischemic stroke. patients will be randomized to receive a 14-day treatment of placebo or mildronate (500mg/5ml/each).Primary end-point is the modified Rankin scale at 3 monthes. Secondary end-point is the NIHSS scores and the Barthel index at 8 days and 15days. The safety end-point is defined as the incidence of adverse events, the change of Samples for routine laboratory tests and vital signs. Analysis is by intention to treat.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Ischemic Stroke
  • Drug: infusion of mildronate
    infusion of mildronate(500mg) once a day and for 14 days
  • Drug: placebo
    infusion of plabcebo once a day and for 14 days
  • Drug: aspirin
    infusion of aspirin (100mg) once a day for days
  • Experimental: mildronate
    infusion of mildronate
    Interventions:
    • Drug: infusion of mildronate
    • Drug: aspirin
  • Placebo Comparator: placebo
    infusion of placebo mildronate
    Interventions:
    • Drug: placebo
    • Drug: aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
August 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

- have a clinical diagnosis of acute ischemic stroke have CT or MRI brain imaging NIHSS scores:5~22 on the first stage

Exclusion Criteria:

- have other intracranial pathologies are pregnant or nursing have significant drug or alcohol misuse have been in a clinical trial in the past 3 months are unlikely to be available for follow-up have been given thrombolytic therapy or medication forbidden by study protocol have a neurological or psychiatric disease

Both
18 Years to 80 Years
No
Contact: Gang Zhao, MD 02984775361 zhaogang@fmmu.edu.cn
China
 
NCT01800357
xijing-007
Yes
Xijing Hospital
Xijing Hospital
Not Provided
Study Director: Gang Zhao, MD the Department of Neurology , Xijing Hospital
Study Chair: Yi Zhu, MD the Department of Neurology , Xijing Hospital
Xijing Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP