Acute Ischemic StrokePhase 2NCT01800357
Efficacy and Safety of Mildronate for Acute Ischemic Stroke
A Phase 2 study testing infusion of mildronate and aspirin in people with Acute Ischemic Stroke, run by Xijing Hospital at 1 site in China.
Trial summary
This study seeks 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?
- infusion of mildronate and aspirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Aug 2014
- 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
- have a clinical diagnosis of acute ischemic stroke have CT or MRI brain imaging NIHSS scores:5~22 on the first stage
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Department of Neurology , Xijing Hospital
Xi'an, Shaanxi, 710032
Gang Zhao, MD, 02984775361, zhaogang@fmmu.edu.cn
Yi Zhu, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- infusion of mildronate, placebo, 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.
infusion of mildronateDrug
infusion of mildronate(500mg) once a day and for 14 days
placeboDrug
infusion of plabcebo once a day and for 14 days
aspirinDrug
infusion of aspirin (100mg) once a day for days
| Study group | Role | What they receive |
|---|---|---|
| mildronate | Experimental | infusion of mildronate Receives: Drug: infusion of mildronate; Drug: aspirin |
| placebo | Placebo comparator | infusion of placebo mildronate Receives: Drug: placebo; 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 (4)
NIHSS scores
Measured: 8 days
NIHSS scores
Measured: 15 days
the Barthel index
Measured: 8 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 posted27 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2014 (estimated)
- Study completionAug 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.
- 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
- 240 participants (estimated)
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 HospitalYi Zhu, MD, Study chair, the Department of Neurology , Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800357
- Sponsor's protocol ID
- xijing-007
- Status last verified
- Jan 2013
- First submitted
- 25 Feb 2013
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 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: Study Protocol for a Randomized, Double-blind, Placebo-controlled Phase II Multicenter Trial
- ClinicalTrials.gov ID
- NCT01800357
- Acronym / sponsor ID
- xijing-007
- Conditions
- Acute Ischemic Stroke
- Keywords
- randomized trial, acute ischemic stroke, mildronate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 27 Feb 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.
This study seeks to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke
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.
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: infusion of mildronate, Drug: aspirininfusion of mildronate |
| placebo | Placebo comparator | Drug: placebo, Drug: aspirininfusion of placebo mildronate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- have a clinical diagnosis of acute ischemic stroke have CT or MRI brain imaging NIHSS scores:5~22 on the first stage
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| infusion of mildronateinfusion of mildronate(500mg) once a day and for 14 days | Drug | mildronate |
| placeboinfusion of plabcebo once a day and for 14 days | Drug | placebo |
| aspirininfusion of aspirin (100mg) once a day for days | Drug | mildronate, placebo |
Primary outcome
the modified Rankin scale
Time frame: 3 months
4 secondary outcomes
NIHSS scores
Time frame: 8 days
NIHSS scores
Time frame: 15 days
the Barthel index
Time frame: 8 days
the Barthel index
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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
Yi Zhu, MD study chair
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 infusion of mildronate 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: status not confirmed, as of the sponsor's last update on 27 Feb 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Zhao, MD (02984775361, zhaogang@fmmu.edu.cn), or a site near the patient. 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 27 Feb 2013.