StrokePhase 2/3NCT02878772
Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke Patients
A Phase 2/3 study testing vinpocetine and Aspirin in people with Stroke and Immunoregulation, run by Tianjin Medical University General Hospital.
Trial summary
Immunity and inflammation play critical roles in the pathogenesis of acute ischemic stroke. Therefore, immune intervention, as a new therapeutic strategy, is worthy of exploration. Here, investigators tested the inflammation modulator, vinpocetine, for its effect on the outcomes of stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Immunoregulation, Inflammation
- What is being tested?
- vinpocetine and Aspirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2015
- Phase
- Phase 2/3
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years of age
- Anterior-circulation ischemic stroke: All patients had symptoms of focal neurological deficits and simultaneous radiological evidence (magnetic resonance imaging, MRI) of an ischemic brain lesion
- measurable neurological deficit (NIHSS > 5)
- interval between symptom onset and admission more than 4.5 hours and less than 48 hours. That is, all patients we recruited were beyond the 4.5 hours of symptom onset and, therefore, past the accepted time-window for thrombolytic therapy
Who cannot join
- hemorrhagic stroke and severe hemorrhage in other organs
- other diseases of the central nervous system (CNS)
- diabetes mellitus
- tumor or hematological systemic diseases
- any infection before acute ischemic stroke
- concomitant use of antineoplastic or immune modulating therapies
- contraindication to MRI
About this study
Official title: Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke
Immunity and inflammation play critical roles in the pathogenesis of acute ischemic stroke. Therefore, immune intervention, as a new therapeutic strategy, is worthy of exploration. Here, investigators tested the inflammation modulator, vinpocetine, for its effect on the outcomes of stroke. For this multi-center study, investigators recruited 60 patients with anterior cerebral circulation occlusion and onset of stroke that had exceeded 4.5 hours but lasted less than 48 hours. These patients, after randomly division into two groups, received either standard management alone (controls) or standard management plus vinpocetine (30 mg per day intravenously for 14 consecutive days, Gedeon Richter Plc., Hungary).
- Conditions
- Stroke, Immunoregulation, Inflammation, Vinpocetine
- Being tested
- vinpocetine, Aspirin
- Medical subject headings
- Stroke, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vinpocetineDrug
Also called Cavinton
30 mg of the drug by intravenous infusion once daily, for fourteen consecutive days, beginning within one hour after the baseline MRI and no later than 48 hours after the onset of symptoms.
AspirinDrug
100mg, once daily, oral medication
| Study group | Role | What they receive |
|---|---|---|
| vinpocetine group | Active comparator | Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days Receives: Drug: vinpocetine; Drug: Aspirin |
| Control group | Placebo comparator | Patients will receive aspirin only. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in lesion volume
changes in lesion volume from baseline (DWI) to day 7 (Flair)
Measured: lesion volume from baseline to day 7
brain inflammatory level
brain inflammatory level (MRS) at day 7
Measured: day 7
extent of clinical improvement
extent of clinical improvement at day 7 and 14, as measured by the changes on the NIHSS score from baseline to day 7 and 14
Measured: from baseline to day 7 and 14
Secondary outcomes (2)
probability of excellent recovery
probability of excellent recovery at day 90 (defined as a score of 0 or 1 on the mRS)
Measured: at day 90
cytotoxic edema
cytotoxic edema of day 3 (ADC value).
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
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 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junwei Hao, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878772
- Sponsor's protocol ID
- TianjinMUGH1
- Status last verified
- Aug 2016
- First submitted
- 4 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Zhang F, Yan C, Wei C, Yao Y, Ma X, Gong Z, Liu S, Zang D, Chen J, Shi FD, Hao J. Vinpocetine Inhibits NF-kappaB-Dependent Inflammation in Acute Ischemic Stroke Patients. Transl Stroke Res. 2018 Apr;9(2):174-184. doi: 10.1007/s12975-017-0549-z. Epub 2017 Jul 9.
PubMed 28691141
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02878772
- Acronym / sponsor ID
- TianjinMUGH1
- Conditions
- Stroke, Immunoregulation, Inflammation, Vinpocetine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Aug 2016 (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.
Immunity and inflammation play critical roles in the pathogenesis of acute ischemic stroke. Therefore, immune intervention, as a new therapeutic strategy, is worthy of exploration. Here, investigators tested the inflammation modulator, vinpocetine, for its effect on the outcomes of stroke. For this multi-center study, investigators recruited 60 patients with anterior cerebral circulation occlusion and onset of stroke that had exceeded 4.5 hours but lasted less than 48 hours. These patients, after randomly division into two groups, received either standard management alone (controls) or standard management plus vinpocetine (30 mg per day intravenously for 14 consecutive days, Gedeon Richter Plc., Hungary).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vinpocetine group | Active comparator | Drug: vinpocetine, Drug: AspirinAspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days |
| Control group | Placebo comparator | Drug: AspirinPatients will receive aspirin only. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years of age
- Anterior-circulation ischemic stroke: All patients had symptoms of focal neurological deficits and simultaneous radiological evidence (magnetic resonance imaging, MRI) of an ischemic brain lesion
- measurable neurological deficit (NIHSS > 5)
- interval between symptom onset and admission more than 4.5 hours and less than 48 hours. That is, all patients we recruited were beyond the 4.5 hours of symptom onset and, therefore, past the accepted time-window for thrombolytic therapy
Key exclusion criteria (7 listed)
- hemorrhagic stroke and severe hemorrhage in other organs
- other diseases of the central nervous system (CNS)
- diabetes mellitus
- tumor or hematological systemic diseases
- any infection before acute ischemic stroke
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 |
|---|---|---|
| vinpocetineAlso: Cavinton30 mg of the drug by intravenous infusion once daily, for fourteen consecutive days, beginning within one hour after the baseline MRI and no later than 48 hours after the onset of symptoms. | Drug | vinpocetine group |
| Aspirin100mg, once daily, oral medication | Drug | Control group, vinpocetine group |
Primary outcome
changes in lesion volume
Time frame: lesion volume from baseline to day 7
changes in lesion volume from baseline (DWI) to day 7 (Flair)
brain inflammatory level
Time frame: day 7
brain inflammatory level (MRS) at day 7
extent of clinical improvement
Time frame: from baseline to day 7 and 14
extent of clinical improvement at day 7 and 14, as measured by the changes on the NIHSS score from baseline to day 7 and 14
2 secondary outcomes
probability of excellent recovery
Time frame: at day 90
cytotoxic edema
Time frame: day 3
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 25 Aug 2016.
- Derived from this study: PubMed 28691141Zhang F, Yan C, Wei C, Yao Y, Ma X, Gong Z, Liu S, Zang D, Chen J, Shi FD, Hao J. Vinpocetine Inhibits NF-kappaB-Dependent Inflammation in Acute Ischemic Stroke Patients. Transl Stroke Res. 2018 Apr;9(2):174-184. doi: 10.1007/s12975-017-0549-z. Epub 2017 Jul 9.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing vinpocetine and Aspirin in people with Stroke and Immunoregulation, run by Tianjin Medical University General Hospital.
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 4 inclusion and 7 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 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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?
changes in lesion volume (time frame: lesion volume from baseline to day 7). The study lists 3 primary outcomes in all. 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 NCT02878772, 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 25 Aug 2016.