Ischemic StrokePhase 3BNG-1NCT01675115
Efficacy of BNG-1 to Treat Acute Ischemic Stroke
A Phase 3 study testing BNG-1 and Aspirin in people with Ischemic Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The objective of this study is to investigate the efficacy and safety of BNG-1 in patients with ischemic stroke. The efficacy assessment will be based on the functional outcome while the safety will be reviewed by the adverse events and laboratory examinations. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- BNG-1 and Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Nov 2014
- Phase
- Phase 3
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders and ages 20 through 65 (subjects are at least 20 years old but not yet 66).
- Clinical diagnosis of ischemic stroke, causing a measurable neurological deficit.
- Onset of symptoms of ischemic stroke within 10 days of initiation of treatment with the study drug.
- Patients have a total National Institutes of Health Stroke Scale (NIHSS) between 8 and 22 inclusive by the time of randomization.
- Patients have a total Barth Index (BI) less than 60 or Modified Rankin Scale (MRS) at least 3 by the time of randomization.
- No previous history of stroke or previous stroke with Modified Rankin Scale < 1.
- Patient must have a CT or MRI examination compatible with the clinical diagnosis of acute ischemic stroke.
- Signed informed consent from patient or legally authorized representative.
Who cannot join
- Patient has only major symptoms that are rapidly improving by the time of randomization.
- History of stroke within the previous 3 months, exclude TIA.
- Patient has a CT or MRI scan with evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage.
- Patients with known or suspected prior intracranial haemorrhage or history of brain injury or brain tumor.
- Patient had documented history of any atrial fibrillation occurring 6 months before randomization.
- Hypertension, defined as systolic blood pressure > 185 mmHg or diastolic blood pressure >110 mmHg or requiring aggressive (eg, intravenous antihypertensive) treatment to reduce blood pressure to within these limits.
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- Recurrent peptic ulcer or gastrointestinal bleeding documented by radiographic or endoscopic means within the past 3 months.
- Pregnant or lactating women or women of childbearing potential who are not practicing reliable birth control.
- Platelet count less than 100,000 cells/ml.
- Activated partial thromboplastin time (aPTT) prolongation greater than 2 seconds above the upper limit of normal for local laboratory.
- International normalized ratio (INR) greater than or equal to 1.4.
- Uncontrolled hyperglycemia (Sugar AC > 200 mg/dl).
- History of alcohol or drug abuse in the previous 3 months.
- History of hypersensitivity or intolerance of study drug or aspirin.
- Neurological (other than the presenting stroke) or psychiatric conditions that may affect the patient's functional status and/or that may interfere with the patient's assessment.
- Previously in the BRAIN-Study or participation in a research protocol for investigation of a pharmaceutical agent or innovative invasive procedure within the past 30 days.
- Any other known clinically significant medical disorder (e.g., a severe comorbid disease or dementia, transient cerebral ischemia, lower gastrointestinal bleeding, bleeding diathesis, hepatorenal diseases, cancer, and AIDS).
- Patients who have received anticoagulant agents, antiplatelet agents (except Aspirin), thrombolytics with 48-hour before randomization.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Stroke center, Department of Neurology, Linkou Chang Gung Memorial Hospital
Kweishan, Taoyuan, 333
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Compare the Functional Outcome and Safety of Treatment With BNG-1 in Combination With Aspirin With That of Aspirin Alone in Ischemic Stroke Recovery
The objective of this study is to investigate the efficacy and safety of BNG-1 in patients with ischemic stroke. The efficacy assessment will be based on the functional outcome while the safety will be reviewed by the adverse events and laboratory examinations.
Read the detailed description
The primary endpoint will be performed on the 12 weeks after study drug administered and will compare the favorable rate between treatment with Aspirin alone and combination treatment with BNG-1 and Aspirin in patients with ischemic stroke. The favorable to therapy will be determined if all of the following occurs: alive, Modified Rankin Scale (MRS) < 3, Barthel Index (BI) >= 60.
Secondary objectives are to compare the following:
- Compare the favorable rate at one week after study drug administered and the end of treatment (Week 4) and 4 weeks of follow-up (Week 8) of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
- Compare the mean change in Barthel Index (BI), at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
- Compare the mean change in National Institute of Health Stroke Scale (NIHSS) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
- Compare the Modified Rankin Scale (MRS) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
- Compare the change in Extended Glasgow Outcome Scale (GOS-E) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
- Conditions
- Ischemic Stroke
- Being tested
- BNG-1, Aspirin
- Keywords
- Ischemic stroke, Traditional Chinese Medication, Aspirin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNG-1Drug
BNG-1 3 grams TID for 4 weeks
AspirinDrug
Aspirin 100 mg QD for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| BNG-1 plus Aspirin | Active comparator | BNG-1 3 grams TID plus Aspirin 100mg QD for 4 weeks Receives: Drug: BNG-1 |
| Aspirin | Sham comparator | Aspirin 100mg QD for 4 weeks Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable rate
Favorite rate: A composite of mortality (alive), modified Rankin Scale < 3, AND Barthel Index (BI)>=60
Measured: 12 weeks
Secondary outcomes (5)
Favorable rate
Measured: 12 weeks
Barthel index
Measured: 12 weeks
Modified Rankin Scale
Measured: 12 weeks
National Institute of Health Stroke Scale
Measured: 12 weeks
Extended Glasgow Outcome Scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsong-Hai Lee, Chang Gung Memorial Hospital
- Investigators
- Tsong-Hai Lee, MD, PhD, Principal investigator, Chief of Stroke Center, Linkou Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675115
- Sponsor's protocol ID
- BNG-1-PIIIB
- Acronym
- BNG-1
- Status last verified
- Jul 2015
- First submitted
- 2 Apr 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsieh CY, Lin HJ. Letter by Hsieh and Lin Regarding Article, "Acute Reperfusion Therapy and Stroke Care in Asia After Successful Endovascular Trials". Stroke. 2015 Aug;46(8):e198. doi: 10.1161/STROKEAHA.115.010253. Epub 2015 Jul 2. No abstract available.
PubMed 26138124
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Compare the Functional Outcome and Safety of Treatment With BNG-1 in Combination With Aspirin With That of Aspirin Alone in Ischemic Stroke Recovery
- ClinicalTrials.gov ID
- NCT01675115
- Acronym / sponsor ID
- BNG-1 / BNG-1-PIIIB
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic stroke, Traditional Chinese Medication, Aspirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Aug 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 objective of this study is to investigate the efficacy and safety of BNG-1 in patients with ischemic stroke. The efficacy assessment will be based on the functional outcome while the safety will be reviewed by the adverse events and laboratory examinations.
Detailed description
The primary endpoint will be performed on the 12 weeks after study drug administered and will compare the favorable rate between treatment with Aspirin alone and combination treatment with BNG-1 and Aspirin in patients with ischemic stroke. The favorable to therapy will be determined if all of the following occurs: alive, Modified Rankin Scale (MRS) < 3, Barthel Index (BI) >= 60.
Secondary objectives are to compare the following:
- Compare the favorable rate at one week after study drug administered and the end of treatment (Week 4) and 4 weeks of follow-up (Week 8) of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
- Compare the mean change in Barthel Index (BI), at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
- Compare the mean change in National Institute of Health Stroke Scale (NIHSS) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
- Compare the Modified Rankin Scale (MRS) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
- Compare the change in Extended Glasgow Outcome Scale (GOS-E) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
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 |
|---|---|---|
| BNG-1 plus Aspirin | Active comparator | Drug: BNG-1BNG-1 3 grams TID plus Aspirin 100mg QD for 4 weeks |
| Aspirin | Sham comparator | Drug: AspirinAspirin 100mg QD for 4 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Both genders and ages 20 through 65 (subjects are at least 20 years old but not yet 66).
- Clinical diagnosis of ischemic stroke, causing a measurable neurological deficit.
- Onset of symptoms of ischemic stroke within 10 days of initiation of treatment with the study drug.
- Patients have a total National Institutes of Health Stroke Scale (NIHSS) between 8 and 22 inclusive by the time of randomization.
- Patients have a total Barth Index (BI) less than 60 or Modified Rankin Scale (MRS) at least 3 by the time of randomization.
Key exclusion criteria (18 listed)
- Patient has only major symptoms that are rapidly improving by the time of randomization.
- History of stroke within the previous 3 months, exclude TIA.
- Patient has a CT or MRI scan with evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage.
- Patients with known or suspected prior intracranial haemorrhage or history of brain injury or brain tumor.
- Patient had documented history of any atrial fibrillation occurring 6 months before randomization.
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 |
|---|---|---|
| BNG-1BNG-1 3 grams TID for 4 weeks | Drug | BNG-1 plus Aspirin |
| AspirinAspirin 100 mg QD for 4 weeks | Drug | Aspirin |
Primary outcome
Favorable rate
Time frame: 12 weeks
Favorite rate: A composite of mortality (alive), modified Rankin Scale < 3, AND Barthel Index (BI)>=60
5 secondary outcomes
Favorable rate
Time frame: 12 weeks
Barthel index
Time frame: 12 weeks
Modified Rankin Scale
Time frame: 12 weeks
National Institute of Health Stroke Scale
Time frame: 12 weeks
Extended Glasgow Outcome Scale
Time frame: 12 weeks
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 28 Jul 2015.
- Derived from this study: PubMed 26138124Hsieh CY, Lin HJ. Letter by Hsieh and Lin Regarding Article, "Acute Reperfusion Therapy and Stroke Care in Asia After Successful Endovascular Trials". Stroke. 2015 Aug;46(8):e198. doi: 10.1161/STROKEAHA.115.010253. Epub 2015 Jul 2. No abstract available.
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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.
Tsong-Hai Lee, MD, PhD principal investigator
Chief of Stroke Center, Linkou Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BNG-1 and Aspirin in people with Ischemic Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 8 inclusion and 18 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 28 Jul 2015. 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 Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Favorable rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01675115, which also lists 1 linked publication.
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 28 Jul 2015.