Acute Ischemic StrokePhase 2NCT01831011
Mildronate for Acute Ischemic Stroke
A Phase 2 study testing mildronate injection, cinepazide maleate injection and aspirin in people with Acute Ischemic Stroke, run by Xijing Hospital at 1 site in China.
Trial summary
Mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic drug. This study aims to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- mildronate injection, cinepazide maleate injection and aspirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteChina
- Study dates
- Jul 2008to Apr 2010
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (i) had a clinical diagnosis of acute ischaemic stroke ,on the first episode within the previous 7 days, and confirmed on CT or MRI brain imaging.(ii) were between 18 to 80 years of age (patients >= 70 years were not combined with any other poor physical condition except ischaemic stroke )(iii)had a score of 5-22 on the National Institutes of Health Stroke Scale (NIHSS).(iv)had a report that liver and kedney function were less than 1.5 folds of normal value.
Who cannot join
- (i) had other intracranial pathologies (e.g. cerebral hemorrhage, tumour, infection), (ii) were pregnant or nursing ;(iii) had a neurological or psychiatric disease ;(iv) had significant drug or alcohol misuse, (v)had been given thrombolytic therapy or medication forbidden by study protocol; (vi)participated in a clinical trial in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Mildronate for Acute Ischemic Stroke: a Randomized, Double-blind, Active-controlled Phase II Multicenter Trial
Mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic drug. This study aims to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke.
Read the detailed description
A randomized, double-blind, multi-center clinical study was made on mildronate injection for treating acute cerebral infarction. 113 cases in the experimental group were given with mildronate injection, while 114 cases in the active-control group were given with cinepazide maleate injection. In addition, both groups were given aspirin as basic treatments. Modified Rankin Scale (mRS) score at 2 weeks and 3 months, National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index score at 2 weeks after treatment, vital signs and adverse events were evaluated.
- Conditions
- Acute Ischemic Stroke
- Being tested
- mildronate injection, cinepazide maleate injection, aspirin
- Keywords
- randomized trial, acute ischemic stroke, mildronate
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mildronate injectionDrug
Also called infusion of mildronate infusion of mildronate(500mg) once a day and for 14 da
cinepazide maleate injectionDrug
Also called infusion of plabcebo once a day and for 14 days
aspirinDrug
Also called infusion of aspirin (100mg) once a day for days
| Study group | Role | What they receive |
|---|---|---|
| mildronate | Experimental | infusion of mildronate Receives: Drug: mildronate injection; Drug: aspirin |
| cinepazide maleate | Active comparator | infusion of cinepazide maleate Receives: Drug: cinepazide maleate injection; Drug: aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the modified Rankin scale
Measured: 3 months
Secondary outcomes (2)
NIHSS scores
Measured: 15 days
the Barthel index
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startJul 2008
- Primary completionApr 2010
- Study completionApr 2010
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.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Zhao, MD, Study director, the Department of Neurology , Xijing HospitalGuang Yun Zhang, MD, Principal investigator, the Department of Neurology , Xijing HospitalYi Zhu, MD, Principal investigator, the Department of Neurology , Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831011
- Sponsor's protocol ID
- xijing-008
- Status last verified
- Apr 2013
- First submitted
- 10 Apr 2013
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Mildronate for Acute Ischemic Stroke: a Randomized, Double-blind, Active-controlled Phase II Multicenter Trial
- ClinicalTrials.gov ID
- NCT01831011
- Acronym / sponsor ID
- xijing-008
- Conditions
- Acute Ischemic Stroke
- Keywords
- randomized trial, acute ischemic stroke, mildronate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 Apr 2013 (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.
Mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic drug. This study aims to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke.
Detailed description
A randomized, double-blind, multi-center clinical study was made on mildronate injection for treating acute cerebral infarction. 113 cases in the experimental group were given with mildronate injection, while 114 cases in the active-control group were given with cinepazide maleate injection. In addition, both groups were given aspirin as basic treatments. Modified Rankin Scale (mRS) score at 2 weeks and 3 months, National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index score at 2 weeks after treatment, vital signs and adverse events were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mildronate | Experimental | Drug: mildronate injection, Drug: aspirininfusion of mildronate |
| cinepazide maleate | Active comparator | Drug: cinepazide maleate injection, Drug: aspirininfusion of cinepazide maleate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (i) had a clinical diagnosis of acute ischaemic stroke ,on the first episode within the previous 7 days, and confirmed on CT or MRI brain imaging.(ii) were between 18 to 80 years of age (patients >= 70 years were not combined with any other poor physical condition except ischaemic stroke )(iii)had a score of 5-22 on the National Institutes of Health Stroke Scale (NIHSS).(iv)had a report that liver and kedney function were less than 1.5 folds of normal value.
Key exclusion criteria (1 listed)
- (i) had other intracranial pathologies (e.g. cerebral hemorrhage, tumour, infection), (ii) were pregnant or nursing ;(iii) had a neurological or psychiatric disease ;(iv) had significant drug or alcohol misuse, (v)had been given thrombolytic therapy or medication forbidden by study protocol; (vi)participated in a clinical trial in the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mildronate injectionAlso: infusion of mildronate infusion of mildronate(500mg) once a day and for 14 da | Drug | mildronate |
| cinepazide maleate injectionAlso: infusion of plabcebo once a day and for 14 days | Drug | cinepazide maleate |
| aspirinAlso: infusion of aspirin (100mg) once a day for days | Drug | cinepazide maleate, mildronate |
Primary outcome
the modified Rankin scale
Time frame: 3 months
2 secondary outcomes
NIHSS scores
Time frame: 15 days
the Barthel index
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2013.
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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.
Gang Zhao, MD study director
the Department of Neurology , Xijing Hospital
Guang Yun Zhang, MD principal investigator
the Department of Neurology , Xijing Hospital
Yi Zhu, MD principal investigator
the Department of Neurology , Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mildronate injection, cinepazide maleate injection and aspirin in people with Acute Ischemic Stroke, run by Xijing Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Apr 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the modified Rankin scale (time frame: 3 months). 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 12 Apr 2013.