Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke (CER)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
yongjun wang, Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier:
NCT01556854
First received: March 13, 2012
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

The primary objective of this study is to compare effectiveness of five different neuroprotectants, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.

The secondary objectives of the study are as follows:

  • To compare safety of five different neuroprotectents, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.
  • To compare cost-effectiveness of five different neuroprotectents, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.

Condition
Acute Ischemic Stroke

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparative Effectiveness of Different Neuroprotectants Among Patients With Acute Ischemic Stroke in Clinical Practice

Further study details as provided by Ministry of Science and Technology of the People´s Republic of China:

Primary Outcome Measures:
  • Effectiveness Outcome Measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • The severity of neurological impairment evaluated by the NIHSS • Disability by mRS
    • All cause mortality
    • In-hospital recurrence and recurrence at 3 month post discharge
    • In-hospital complications
    • Cognitive disorder evaluated by MMSE
    • Quality of Life evaluated by EQ5D


Secondary Outcome Measures:
  • Safety Outcome Measures [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    • death
    • prolonged inpatient hospitalization
    • a life-threatening experience (that is, immediate risk of dying)
    • persistent or significant disability/incapacity
    • or is considered significant by the physician for any other reason.

  • Cost-effectiveness Outcome Measures [ Time Frame: 2011.7-2014.6 ] [ Designated as safety issue: No ]
    • Medical cost at discharge
    • Drug cost at discharge
    • Neuroprotectents cost at discharge
    • Administration cost at discharge
    • Medical cost at 3 month post discharge
    • Drug cost at 3 month post discharge


Estimated Enrollment: 20000
Study Start Date: July 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Study Population:The study population will consist of consenting patients who are on neuroprotectant injection for the treatment of acute IS during hospitalization. Hospitals may contribute differing numbers of patients to the total sample size. Primary analyses will be conducted on the total sample size only.

Assessment of Outcomes:The outcome measures in this study include effectiveness, safety and cost measures.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population will consist of consenting patients who are on neuroprotectant injection for the treatment of acute IS during hospitalization.

Criteria

Inclusion Criteria:

  • At least 18 years old
  • Ischemic stroke confirmed by brain CT or MRI within 14 days of the index event
  • Neuroprotectents administrated during hospitalization
  • Direct admission based on physician evaluation or arrival through the emergency department
  • Ability of patient or legally authorized representative (primarily spouse, parents, adult children, otherwise indicated) to provide informed consent.
  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: NCT01556854

Locations
China, Beijing
Tiantan hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Yilong Wang, Doctor    00861067098222    yilong528@Gmail.com   
Sponsors and Collaborators
yongjun wang
  More Information

No publications provided

Responsible Party: yongjun wang, Beijing Tiantan hospital, Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier: NCT01556854     History of Changes
Other Study ID Numbers: 2011BAI08B02-01
Study First Received: March 13, 2012
Last Updated: March 15, 2012
Health Authority: China: Ministry of Science and Technology
China: Ministry of Health

Keywords provided by Ministry of Science and Technology of the People´s Republic of China:
ginkgo leaves
butylphthalide
edaravone
citicoline
cerebrolysin
piracetam
Neuroprotectants

Additional relevant MeSH terms:
Cerebral Infarction
Ischemia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014