Acute Ischemic StrokeCERNCT01556854
Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by yongjun wang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of consenting patients who are on neuroprotectant injection for the treatment of acute IS during hospitalization.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tiantan hospital
Beijing, Beijing Municipality, 100050
Yilong Wang, Doctor, 00861067098222, yilong528@Gmail.com
About this study
Official title: Comparative Effectiveness of Different Neuroprotectants Among Patients With Acute Ischemic Stroke in Clinical Practice
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Keywords
- ginkgo leaves, butylphthalide, edaravone, citicoline, cerebrolysin, piracetam, Neuroprotectants
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness Outcome Measures
- 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
Measured: 3 years
Secondary outcomes (2)
Safety Outcome Measures
- 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.
Measured: 3 years
Cost-effectiveness Outcome Measures
- 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
Measured: 2011.7-2014.6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startJul 2011
- Primary completionNov 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yongjun wang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, yongjun wang, Ministry of Science and Technology of the People´s Republic of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556854
- Sponsor's protocol ID
- 2011BAI08B02-01
- Acronym
- CER
- Status last verified
- Mar 2012
- First submitted
- 13 Mar 2012
- Last updated
- 16 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Different Neuroprotectants Among Patients With Acute Ischemic Stroke in Clinical Practice
- ClinicalTrials.gov ID
- NCT01556854
- Acronym / sponsor ID
- CER / 2011BAI08B02-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- ginkgo leaves, butylphthalide, edaravone, citicoline, cerebrolysin, piracetam, Neuroprotectants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- yongjun wangOther government
- Study start
- Jul 2011
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of consenting patients who are on neuroprotectant injection for the treatment of acute IS during hospitalization.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness Outcome Measures
Time frame: 3 years
* 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
2 secondary outcomes
Safety Outcome Measures
Time frame: 3 years
Cost-effectiveness Outcome Measures
Time frame: 2011.7-2014.6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by yongjun wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness Outcome Measures (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2012; AzTrials last refreshed its copy on 6 Nov 2026.