Cerebral InfarctionPhase 4NCT02248233
Nimodipine for Treating Acute Massive Cerebral Infarction
A Phase 4 study testing Nimodipine and Saline + citicoline in people with Cerebral Infarction, run by Fengtian Hospital.
Trial summary
Massive cerebral infarction is an ischemic stroke caused by complete blockage of the internal carotid artery, middle cerebral artery, or their cortical branches. The widespread infarction, pathological severity and high fatality rate associated with massive cerebral infarction pose a major threat to affected patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Nimodipine and Saline + citicoline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Sep 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First onset at age ≤ 80 years, no other severe medical complications;
- Clear consciousness or mild disturbance of consciousness; paralysis of upper and lower extremities on one side with grade 0-3 muscle strength in paralyzed limbs;
- CT reveals early massive cerebral infarction (without cerebral hemorrhage or old infarction);
- Blood pressure within, or higher than, the normal range.
Who cannot join
- Clinical manifestations are noticeably improved before treatment;
- Disorders of consciousness, manifesting as severe lethargy or coma;
- Mild neurological deficits, such as pure sensory disturbances, ataxia, dysarthria, and hemiparesis;
- Severe hypotension (systolic pressure < 90 mmHg, diastolic pressure < 60 mmHg);
- Heart rate < 60 BPM; sinus bradycardia;
- Severe heart, brain or kidney dysfunction, or malignant tumor.
About this study
Official title: Nimodipine for Treating Acute Massive Cerebral Infarction: a Randomized, Double-blind, Controlled Clinical Study
Massive cerebral infarction is an ischemic stroke caused by complete blockage of the internal carotid artery, middle cerebral artery, or their cortical branches. The widespread infarction, pathological severity and high fatality rate associated with massive cerebral infarction pose a major threat to affected patients. However, there is a lack of unified diagnostic criteria. Many researchers use Adams' classification, in which massive cerebral infarction is diagnosed when the following criteria are met: infarct size > 13 cm2; a major brain-feeding artery is involved; the focal site affects more than two cerebral lobes; infarct diameter line ≥ 3 cm in internal capsule of striatum.
Prolonged cerebral ischemia/reperfusion can induce complex secondary changes in brain tissue, so the use of neuroprotective agents is very important. Remarkable progress has been made over the last decade in understanding the protective effect of calcium antagonists against cerebral ischemia. In particular, the liposoluble dihydropyridine Ca2+ antagonist nimodipine selectively acts on cerebral vessels and neurons and can protect ischemic brain tissue, providing a new way of treating ischemic cerebrovascular disease.
Preclinical and clinical tests have shown that nimodipine has a protective effect on ischemic brain tissue, and indicate that patients should take the drug as soon as possible. However, there are no reports of double-blind, randomized, controlled clinical trials addressing the administration of nimodipine via intravenous drip within the time window for successful treatment of acute massive cerebral infarction.
Read the detailed description
In the clinic, physicians are reluctant to use thrombolysis, Defibrase and anticoagulation therapy because of the severity of symptoms, poor prognosis, risk of hemorrhage and high fatality rate that occur with acute massive cerebral infarction. Nimodipine, as a selective Ca2+ antagonist, is highly liposoluble, effectively crosses the blood-brain barrier, selectively acts on intracranial blood vessels, and is an accepted neuroprotective agent that can be applied in the clinic. The aim of the present study is to perform a double-blind, randomized and controlled trial of the clinical efficacy and safety of nimodipine administered as an intravenous drip in the early stages of acute massive cerebral infarction.
Patients will receive nimodipine within 3 days of infarction onset. We will closely monitor the following: (1) Blood pressure and heart rate of the patient before treatment, since nimodipine is contraindicated in patients with hypotension and low heart rate. Where blood pressure is ≥ 100/80 mmHg and heart rate ≥ 60 BPM, nimodipine will be administered. (2) Speed of infusion. This should not be too fast; we suggest 1-2 drops per minute initially, increasing gradually until the drop in systolic pressure exceeds 10 mmHg. The average drip speed should be 6-8 drops/minute, and the fastest drip speed 10 drops/minute. (3) During the infusion, physicians should monitor adverse reactions such as headache, dizziness, flushing or sweating. If any occur, the infusion speed must be reduced. If the patients remain uncomfortable, nimodipine should be withdrawn. (4) Liver and kidney function should be monitored throughout nimodipine administration.
Although nimodipine is relatively safe, there is still a risk of some adverse effects, such as cardiovascular system reactions (blood pressure decreases, bradycardia, angina, and atrioventricular block), headache, dizziness, edema, and liver and kidney dysfunction. It is necessary to determine the optimal therapeutic time window and dose of nimodipine in multi-center, large-scale clinical trials.
- Conditions
- Cerebral Infarction
- Being tested
- Nimodipine, Saline + citicoline
- Keywords
- nimodipine, acute massive cerebral infarction, Cerebral Infarction, optimal therapeutic time window, optimal dose, multi-center
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimodipineDrug
Also called The treatment group
Jiangsu Jichuan Pharmaceutical Co., Ltd., Jiangsu Province, China
Saline + citicolineDrug
Also called The control group
physiological saline + citicoline 2.0 g, once a day, via intravenous drip, for 10 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Saline + citicoline | Experimental | The control group will receive physiological saline + citicoline 2.0 g, once a day, via intravenous drip, for 10 consecutive days. Patients will receive additional drugs to treat dehydration, prevent infection and upper gastrointestinal bleeding, and maintain water and electrolyte balance. Patients with complications will receive symptomatic treatment. Receives: Drug: Saline + citicoline |
| Nimodipine | Experimental | The treatment group will receive 10 mg of nimodipine in 500 ml of physiological saline via intravenous drip, at a rate of 1-2 drops per minute initially, increasing gradually until systolic pressure decreases by 10 mmHg. Maximum drip speed is 10 drops/minute, administered once a day for 7 consecutive days. The nimodipine must be kept in the dark. Blood pressure and heart rate will be monitored throughout the administration period.
Patients in control group will receive additional drugs to treat dehydration, prevent infection and upper gastrointestinal bleeding, and maintain water and electrolyte balance. Patients with complications will receive symptomatic treatment. Receives: Drug: Nimodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological deficits
Neurological deficits after stroke will be assessed using the National Institute of Health Stroke Scale scores
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fengtian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Runhui Li, Fengtian Hospital
- Investigators
- Runhui Li, M.D., Principal investigator, Central Hospital Affiliated to Shenyang Medical Collage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248233
- Sponsor's protocol ID
- FengtianH-RHL-001
- Status last verified
- Apr 2018
- First submitted
- 22 Sep 2014
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nimodipine for Treating Acute Massive Cerebral Infarction: a Randomized, Double-blind, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02248233
- Acronym / sponsor ID
- FengtianH-RHL-001
- Conditions
- Cerebral Infarction
- Keywords
- nimodipine, acute massive cerebral infarction, Cerebral Infarction, optimal therapeutic time window, optimal dose, multi-center
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fengtian HospitalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Sep 2014 (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.
Massive cerebral infarction is an ischemic stroke caused by complete blockage of the internal carotid artery, middle cerebral artery, or their cortical branches. The widespread infarction, pathological severity and high fatality rate associated with massive cerebral infarction pose a major threat to affected patients. However, there is a lack of unified diagnostic criteria. Many researchers use Adams' classification, in which massive cerebral infarction is diagnosed when the following criteria are met: infarct size > 13 cm2; a major brain-feeding artery is involved; the focal site affects more than two cerebral lobes; infarct diameter line ≥ 3 cm in internal capsule of striatum.
Prolonged cerebral ischemia/reperfusion can induce complex secondary changes in brain tissue, so the use of neuroprotective agents is very important. Remarkable progress has been made over the last decade in understanding the protective effect of calcium antagonists against cerebral ischemia. In particular, the liposoluble dihydropyridine Ca2+ antagonist nimodipine selectively acts on cerebral vessels and neurons and can protect ischemic brain tissue, providing a new way of treating ischemic cerebrovascular disease.
Preclinical and clinical tests have shown that nimodipine has a protective effect on ischemic brain tissue, and indicate that patients should take the drug as soon as possible. However, there are no reports of double-blind, randomized, controlled clinical trials addressing the administration of nimodipine via intravenous drip within the time window for successful treatment of acute massive cerebral infarction.
Detailed description
In the clinic, physicians are reluctant to use thrombolysis, Defibrase and anticoagulation therapy because of the severity of symptoms, poor prognosis, risk of hemorrhage and high fatality rate that occur with acute massive cerebral infarction. Nimodipine, as a selective Ca2+ antagonist, is highly liposoluble, effectively crosses the blood-brain barrier, selectively acts on intracranial blood vessels, and is an accepted neuroprotective agent that can be applied in the clinic. The aim of the present study is to perform a double-blind, randomized and controlled trial of the clinical efficacy and safety of nimodipine administered as an intravenous drip in the early stages of acute massive cerebral infarction.
Patients will receive nimodipine within 3 days of infarction onset. We will closely monitor the following: (1) Blood pressure and heart rate of the patient before treatment, since nimodipine is contraindicated in patients with hypotension and low heart rate. Where blood pressure is ≥ 100/80 mmHg and heart rate ≥ 60 BPM, nimodipine will be administered. (2) Speed of infusion. This should not be too fast; we suggest 1-2 drops per minute initially, increasing gradually until the drop in systolic pressure exceeds 10 mmHg. The average drip speed should be 6-8 drops/minute, and the fastest drip speed 10 drops/minute. (3) During the infusion, physicians should monitor adverse reactions such as headache, dizziness, flushing or sweating. If any occur, the infusion speed must be reduced. If the patients remain uncomfortable, nimodipine should be withdrawn. (4) Liver and kidney function should be monitored throughout nimodipine administration.
Although nimodipine is relatively safe, there is still a risk of some adverse effects, such as cardiovascular system reactions (blood pressure decreases, bradycardia, angina, and atrioventricular block), headache, dizziness, edema, and liver and kidney dysfunction. It is necessary to determine the optimal therapeutic time window and dose of nimodipine in multi-center, large-scale clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline + citicoline | Experimental | Drug: Saline + citicolineThe control group will receive physiological saline + citicoline 2.0 g, once a day, via intravenous drip, for 10 consecutive days. Patients will receive additional drugs to treat dehydration, prevent infection and upper gastrointestinal bleeding, and maintain water and electrolyte balance. Patients with complications will receive symptomatic treatment. |
| Nimodipine | Experimental | Drug: NimodipineThe treatment group will receive 10 mg of nimodipine in 500 ml of physiological saline via intravenous drip, at a rate of 1-2 drops per minute initially, increasing gradually until systolic pressure decreases by 10 mmHg. Maximum drip speed is 10 drops/minute, administered once a day for 7 consecutive days. The nimodipine must be kept in the dark. Blood pressure and heart rate will be monitored throughout the administration period. Patients in control group will receive additional drugs to treat dehydration, prevent infection and upper gastrointestinal bleeding, and maintain water and electrolyte balance. Patients with complications will receive symptomatic treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First onset at age ≤ 80 years, no other severe medical complications;
- Clear consciousness or mild disturbance of consciousness; paralysis of upper and lower extremities on one side with grade 0-3 muscle strength in paralyzed limbs;
- CT reveals early massive cerebral infarction (without cerebral hemorrhage or old infarction);
- Blood pressure within, or higher than, the normal range.
Key exclusion criteria (6 listed)
- Clinical manifestations are noticeably improved before treatment;
- Disorders of consciousness, manifesting as severe lethargy or coma;
- Mild neurological deficits, such as pure sensory disturbances, ataxia, dysarthria, and hemiparesis;
- Severe hypotension (systolic pressure < 90 mmHg, diastolic pressure < 60 mmHg);
- Heart rate < 60 BPM; sinus bradycardia;
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: The treatment groupJiangsu Jichuan Pharmaceutical Co., Ltd., Jiangsu Province, China | Drug | Nimodipine |
| Saline + citicolineAlso: The control groupphysiological saline + citicoline 2.0 g, once a day, via intravenous drip, for 10 consecutive days. | Drug | Saline + citicoline |
Primary outcome
Neurological deficits
Time frame: up to 90 days
Neurological deficits after stroke will be assessed using the National Institute of Health Stroke Scale scores
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 1 May 2018.
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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.
Runhui Li, M.D. principal investigator
Central Hospital Affiliated to Shenyang Medical Collage
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nimodipine and Saline + citicoline in people with Cerebral Infarction, run by Fengtian 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 6 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 1 May 2018. 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. 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?
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?
Neurological deficits (time frame: up to 90 days). 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 1 May 2018.