Nimodipine for Treating Acute Massive Cerebral Infarction

NCT02248233 | Completed Phase 4

• 1 other identifier: FengtianH-RHL-001
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Cerebral Infarction

Keywords

nimodipine; acute massive cerebral infarction; Cerebral Infarction; optimal therapeutic time window; optimal dose; multi-center

Outcome Measures

Primary Outcomes (1)

• Neurological deficits

  Neurological deficits after stroke will be assessed using the National Institute of Health Stroke Scale scores

  up to 90 days

Study Arms (2)

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.

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.

Drug: Nimodipine

Interventions

Nimodipine DRUG

Jiangsu Jichuan Pharmaceutical Co., Ltd., Jiangsu Province, China

Also known as: The treatment group

Nimodipine

Saline + citicoline DRUG

physiological saline + citicoline 2.0 g, once a day, via intravenous drip, for 10 consecutive days.

Also known as: The control group

Saline + citicoline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fengtian Hospital: lead

MeSH Terms

Conditions

Cerebral Infarction

Interventions

Nimodipine; Sodium Chloride; Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nicotinic Acids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Runhui Li, M.D.

  Central Hospital Affiliated to Shenyang Medical Collage

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 1, 2018

Record last verified: 2018-04