StrokePhase 4NICENCT01220622
Efficacy and Safety Study of Nimodipine to Prevent Mild Cognitive Impairment After Acute Ischemic Strokes
A Phase 4 study testing Nimodipine in people with Stroke and Mild Cognitive Impairment, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
Trial summary
The trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on cognition impairment after acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke, Mild Cognitive Impairment
- What is being tested?
- Nimodipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 656 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Jul 2012
- Phase
- Phase 4
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects between 30 and 80 years.
- 2. ICD-10 and CT/MRI criteria for acute cerebral infarction.
- 3. Stroke within 7 days after onset.
- 4.based on years of education correction.MMSE>17(illiteracy),MMSE>20(primary school),MMSE>24(others)
- 5. MoCA≤26 at baseline.
- 6.Hachinski ischemic score ≥7 at baseline.
- 7.Expected good compliance to study.
- 8.Informed consent signed.
Who cannot join
- 1.Diagnosis of schizophrenia, major anxiety syndrome, major depression.
- 2.Alzheimer disease, Parkinson disease, Huntington disease, and fronto-temporal dementia.
- 3.Dementia caused by (e.g., central nervous system trauma, tumor, infections, metabolic disorders, normal pressure hydrocephalus, lack of folic acid or vitamin B12, or thyroid hormone deficiency).
- 4.Contraindications to dihydropyridine derivatives.
- 5.Aphasia or other diseases that affect cognitive evaluation.
- 6.Serious arrhythmias, bradycardia (<50 bpm) or tachycardia (>120 bpm); myocardial infarction within the past 6 months; blood pressure <90/60mmHg; severe renal or hepatic insufficiency; severe anemia, Hb<100g/L; severe gastrointestinal disorders; tumor.
- 7.History of epilepsy, use of the antiepileptic drugs.
- 8.CT/MRI showed neurodegenerative changes or other lesions except cerebral ischemia.
Trial locations and contacts
1 site in 1 country.
Wang xuemei, M.D. contact
China1 site, 1 recruiting
- Recruiting
Beijing Tian Tan Hospital, Capital Medical University
Beijing
Feng tao, M.D., 00861067098343, happyft@sina.com
Wang xuemei, M.D., minnie_wxm@hotmail.com
About this study
Official title: Nimodipine Preventing Cognitive Impairment in Ischemic Cerebrovascular Events: A Randomized, Placebo-Controlled, Double-Blind Trial (NICE)
The trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on cognition impairment after acute ischemic stroke.
Read the detailed description
656 patients diagnosed with acute cerebral ischemia disease (onset≤7d) based on ICD-10 and CT/MRI criteria, who have cognitive impairment meeting all of the inclusion criteria and none of the exclusion criteria, will be included and randomized into nimodipine treatment group and the controlled group.Evaluations of cognitive function will be taken at baseline, 1 month, 3 months, and 6 months.
- Conditions
- Stroke, Mild Cognitive Impairment
- Being tested
- Nimodipine, Placebo
- Keywords
- Stroke, Mild cognitive impairment, Nimodipine
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimodipineDrug
Also called Nimodiping Pian
Administration of nimodipine 30mg tid for 6 months
PlaceboDrug
Also called Control group
Administration of placebo 30mg tid for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Nimodipine | Active comparator | Not described Receives: Drug: Nimodipine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with ADAS-cog and MMSE at 6 months in the ITT population
Measured: 6 months
Secondary outcomes (6)
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 6 months in the ITT population
Measured: 6 months
The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months
Measured: 6 months
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with ADAS-cog and MMSE at 3 months in the ITT population
Measured: 3 months
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 3 months in the ITT population
Measured: 3 months
The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month
Measured: 1 month
The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2012 (estimated)
- Study completionJul 2012 (estimated)
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Investigators
- Wang Yongjun, M.D., Principal investigator, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220622
- Sponsor's protocol ID
- BSP-SOP-040
- Acronym
- NICE
- Status last verified
- Oct 2010
- First submitted
- 12 Oct 2010
- Last updated
- 14 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zheng H, Wang Y, Wang A, Li H, Wang D, Zhao X, Wang P, Shen H, Zuo L, Pan Y, Li Z, Meng X, Wang X, Shi W, Ju Y, Liu L, Dong K, Wang C, Sui R, Xue R, Pan X, Niu X, Luo B, Sui Y, Wang H, Feng T, Wang Y; NICE trial group. The efficacy and safety of nimodipine in acute ischemic stroke patients with mild cognitive impairment: a double-blind, randomized, placebo-controlled trial. Sci Bull (Beijing). 2019 Jan 30;64(2):101-107. doi: 10.1016/j.scib.2018.12.006. Epub 2018 Dec 8.
PubMed 36659633
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nimodipine Preventing Cognitive Impairment in Ischemic Cerebrovascular Events: A Randomized, Placebo-Controlled, Double-Blind Trial (NICE)
- ClinicalTrials.gov ID
- NCT01220622
- Acronym / sponsor ID
- NICE / BSP-SOP-040
- Conditions
- Stroke, Mild Cognitive Impairment
- Keywords
- Stroke, Mild cognitive impairment, Nimodipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Study start
- Oct 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 14 Oct 2010 (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 trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on cognition impairment after acute ischemic stroke.
Detailed description
656 patients diagnosed with acute cerebral ischemia disease (onset≤7d) based on ICD-10 and CT/MRI criteria, who have cognitive impairment meeting all of the inclusion criteria and none of the exclusion criteria, will be included and randomized into nimodipine treatment group and the controlled group.Evaluations of cognitive function will be taken at baseline, 1 month, 3 months, and 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimodipine | Active comparator | Drug: Nimodipine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Subjects between 30 and 80 years.
- 2. ICD-10 and CT/MRI criteria for acute cerebral infarction.
- 3. Stroke within 7 days after onset.
- 4.based on years of education correction.MMSE>17(illiteracy),MMSE>20(primary school),MMSE>24(others)
- 5. MoCA≤26 at baseline.
Key exclusion criteria (8 listed)
- 1.Diagnosis of schizophrenia, major anxiety syndrome, major depression.
- 2.Alzheimer disease, Parkinson disease, Huntington disease, and fronto-temporal dementia.
- 3.Dementia caused by (e.g., central nervous system trauma, tumor, infections, metabolic disorders, normal pressure hydrocephalus, lack of folic acid or vitamin B12, or thyroid hormone deficiency).
- 4.Contraindications to dihydropyridine derivatives.
- 5.Aphasia or other diseases that affect cognitive evaluation.
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 |
|---|---|---|
| NimodipineAlso: Nimodiping PianAdministration of nimodipine 30mg tid for 6 months | Drug | Nimodipine |
| PlaceboAlso: Control groupAdministration of placebo 30mg tid for 6 months | Drug | Placebo |
Primary outcome
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with ADAS-cog and MMSE at 6 months in the ITT population
Time frame: 6 months
6 secondary outcomes
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 6 months in the ITT population
Time frame: 6 months
The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months
Time frame: 6 months
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with ADAS-cog and MMSE at 3 months in the ITT population
Time frame: 3 months
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 3 months in the ITT population
Time frame: 3 months
The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month
Time frame: 1 month
The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2010.
- Derived from this study: PubMed 36659633Zheng H, Wang Y, Wang A, Li H, Wang D, Zhao X, Wang P, Shen H, Zuo L, Pan Y, Li Z, Meng X, Wang X, Shi W, Ju Y, Liu L, Dong K, Wang C, Sui R, Xue R, Pan X, Niu X, Luo B, Sui Y, Wang H, Feng T, Wang Y; NICE trial group. The efficacy and safety of nimodipine in acute ischemic stroke patients with mild cognitive impairment: a double-blind, randomized, placebo-controlled trial. Sci Bull (Beijing). 2019 Jan 30;64(2):101-107. doi: 10.1016/j.scib.2018.12.006. Epub 2018 Dec 8.
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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.
Wang xuemei, M.D. contact
Wang Yongjun, M.D. principal investigator
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nimodipine in people with Stroke and Mild Cognitive Impairment, run by Ministry of Science and Technology of the People´s Republic of China 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 8 inclusion and 8 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 14 Oct 2010. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Feng tao, M.D. (00861067098343, happyft@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with ADAS-cog and MMSE at 6 months in the ITT population (time frame: 6 months). 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 NCT01220622, 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 14 Oct 2010.