Adrenomedullin for ischemic stroke study

JRCT ID: jRCT2051190092

Registered date:08/01/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Acute non-embolic ischemic stroke
• Date of first enrollment: 16/01/2020
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Study drug: Adrenomedullin (huAM)
Controls: placebo
Dosage and administration of investigational drug
1) First half cohort
Dosing at 9 ng / kg / min for 8 hours is continued for 7 days. In addition, saline is administered during the drug holiday within 72 hours.
2) Second half cohort
Administer continuously at 9 ng / kg / min for 72 hours. Thereafter, the administration is continued for 8 hours for 4 days.

Outcome(s)

Primary Outcome

(1) Safety: SAE
(2) Efficacy: NIHSS

Secondary Outcome

(1) Safety: AE
(2) Efficacy: mRS

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

1) Patients who have given written informed consent from the patient or the sponsor to participate in the clinical trial
2) Patients of the following age
(1) Up to 6 patients in both cohorts: age between 20 and 75 at the time of obtaining consent
(2) In both cohorts, after age restriction has been lifted: Patients aged 20 to 90 at the time of consent acquisition
3) Patients who can start study drug administration within 24 hours after onset of ischemic stroke
(If the time of onset is unknown, the time last seen normal is the time of onset.)
4) Patients with a new ischemic area confirmed by MRI-DWI
5) Patients with NIHSS scores of 1 or above

Exclude criteria

1) Patients with ischemic stroke of embolic etiology
2) Patients who are likely to develop hemorrhagic transformation (patients with extensive ischemic stroke)
3) Patients who have premorbid mRS scores of 3 or more
4) Patients with active infections
5) Patients who have received or are scheduled to receive drugs or therapy (endovascular treatment, surgical treatment, etc.) not allowed to be used for the underlying disease
6) Patients with severe consciousness impairment (Japan Coma Scale 100 or more)
7) Patients with severe renal impairment (estimated GFR less than 30 mL / min / 1.73m2)
8) Patients with severe liver damage (transaminase AST (GOT) or ALT (GPT) 100 IU / L or more)
9) Patients diagnosed as having active intracranial bleeding disease (intracranial hemorrhage, subarachnoid hemorrhage, etc.) or ruptured cerebral aneurysm by head MRI taken after onset
10) Patients with severe stenosis and obstruction of the basilar artery, internal carotid artery, and middle cerebral artery horizontal part considered to be the cause of cerebral infarction targeted in this study
11) Patients with significant ECG abnormalities (atrioventricular block of 2-3 degrees, extension of QRS interval of 120 ms or more, extension of QTcB of 450 msec or more), or clinically significant heart disease (heart failure, myocardial infarction) , Angina pectoris)
12) Patients with systolic blood pressure less than 120 mmHg
13) Patients whose pulse rate is less than 45 beats / minute or 120 beats / minute or more
14) Patients with substance abuse or alcoholism
15) Patients who cannot perform MRI
16) Patients with malignant tumors or patients who have been treated for malignant tumors
17) Patients who do not give consent to contraception from the date of obtaining consent until the end of the safety evaluation period
18) Pregnant, lactating, and possibly pregnant
19) Patient who participated in another trial within 24 weeks before obtaining consent
20) Patients who have participated in clinical trials or clinical studies using adrenomedullin
21) Patients weighing 100 kg or more (rounded to one decimal place)
22) Other patients judged by the Investigator or Investigator to be ineligible for this study

Related Information

• Primary Sponsor: IHARA MASAFUMI
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development