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
  Purpose

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


Condition Intervention Phase
Acute Ischemic Stroke
Drug: infusion of mildronate
Drug: placebo
Drug: aspirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Mildronate for Acute Ischemic Stroke: Study Protocol for a Randomized, Double-blind, Placebo-controlled Phase II Multicenter Trial

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • the modified Rankin scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mildronate
infusion of mildronate
Drug: infusion of mildronate
infusion of mildronate(500mg) once a day and for 14 days
Drug: aspirin
infusion of aspirin (100mg) once a day for days
Placebo Comparator: placebo
infusion of placebo mildronate
Drug: placebo
infusion of plabcebo once a day and for 14 days
Drug: aspirin
infusion of aspirin (100mg) once a day for days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800357

Contacts
Contact: Gang Zhao, MD 02984775361 zhaogang@fmmu.edu.cn

Locations
China, Shaanxi
the Department of Neurology , Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Gang Zhao, MD    02984775361    zhaogang@fmmu.edu.cn   
Principal Investigator: Yi Zhu, MD         
Principal Investigator: Guang Yun Zhang, MD         
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Director: Gang Zhao, MD the Department of Neurology , Xijing Hospital
Study Chair: Yi Zhu, MD the Department of Neurology , Xijing Hospital
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01800357     History of Changes
Other Study ID Numbers: xijing-007
Study First Received: February 25, 2013
Last Updated: February 25, 2013
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Aspirin
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014