Ignite Creation Date:
2024-05-06 @ 3:15 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02248233
Status:
COMPLETED
Last Update Posted:
2018-05-01
First Post:
2014-09-22
Brief Title:
Nimodipine for Treating Acute Massive Cerebral Infarction
Sponsor:
Fengtian Hospital
Organization:
Fengtian Hospital
Study Overview
Official Title:
Nimodipine for Treating Acute Massive Cerebral Infarction a Randomized Double-blind Controlled Clinical Study
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 ischemiareperfusion 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
Prolonged cerebral ischemiareperfusion 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 10080 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 dropsminute and the fastest drip speed 10 dropsminute 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
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 10080 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 dropsminute and the fastest drip speed 10 dropsminute 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None