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Table 1 Study inclusion and exclusion criteria

From: Safety and Optimal Neuroprotection of neu2000 in acute Ischemic stroke with reCanalization: study protocol for a randomized, double-blinded, placebo-controlled, phase-II trial

Inclusion criteria

1. Age ≥ 19 years

2. Subject who is presented to hospitals after onset of brain ischemic symptoms from the base of last normal state and can start endovascular therapy in accordance with standard practice guidelines within 8 h after the symptom onset

3. NIHSS ≥8 at screening time point

4. Subject whose activity is possible without the help of others in the general condition 1 day before the ischemic stroke onset and prestroke Barthel Index scores > 90

5. Subject whose cerebral CT and CTA imaging confirm acute ischemic stroke and symptomatic intracranial occlusion at screening and whose occlusion site considered the cause of acute ischemic stroke meets the following conditions: T- or L-type ICA occlusion, MCA M1 occlusion, MCA-M1 equivalent (2 or more MCA-M2, anterior temporal artery is not regarded M2)

6. Subject with ASPECTS ≥ 6 on cerebral non-contrast CT

7. Subject who spontaneously submit a written informed consent to participate in this trial

Clinical exclusion criteria

1. A medical history of hypersensitivity against aspirin (salicylates), sulfasalazine, or 5-ASA

2. Subject whose heart diseases were confirmed at screening: Subject who was diagnosed with myocardial infarction within 6 months; subject who had severe arrhythmia evoking clinical symptoms (respiratory difficulties, tachycardia, etc.) within 6 months; subject whose ECG measured at the emergency room confirms the following results: A. pulse rate < 50 or > 120 beats/min. B. 2nd or 3rd degree AV block. C. congenital or acquired QT syndrome. D. ventricular pre-excitation syndrome

3. Subject who was diagnosed with heart failure ≥ New York Heart Association class II

 Class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities

 Class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion

 Class III: patients with marked limitation of activity; they are comfortable only at rest

 Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest

4. Subject who has a contraindication to iodinated contrast media

5. Subject who is receiving renal replacement therapy such as dialysis due to acute or chronic renal failure

6. Subject who is diagnosed with cancer or received cancer therapy within 6 months or has recurrent or metastatic cancer

7. Subject who shows a high body temperature of 38 °C or more or who need antibiotic therapy due to infectious diseases

8. Subject who takes pharmacotherapy for liver diseases such as hepatitis or liver cirrhosis

9. Subject who is pregnant or lactating. In case of women of child-bearing potential, only subjects who are confirmed as not being pregnant can participate in this trial

10. Subject who participated in other clinical studies within the past 3 months. In case of participation in an observational study without medication, the subject can participate in this trial

11. Subject who was determined inappropriate for participation in this trial due to other reasons

Imaging exclusion criteria

1. Baseline CT evidence of intracranial hemorrhage

2. Baseline CT evidence of intracranial tumor on presentation

3. Baseline CTA shows that the site of occlusion considered to be the cause of acute ischemic stroke meets the following conditions:

 A. MCA + PCA or MCA + ACA occlusion in carotid T/L-type

 B. Occlusion of a bilateral intracranial large artery

 C. Simultaneous involvement of anterior and posterior circulation

4. Absence of the collateral circulation corresponding to one of the followings: CTA imaging shows absence or minimal collateral circulation at ≤ 50% of MCA territories, compared with pial filling of the contralateral side

  1. NIHSS National Institutes of Health Stroke Scale, CT computed tomography, CTA computed tomography angiography, ICA internal carotid artery, MCA middle cerebral artery, ASPECTS Alberta Stroke Program Early CT Score, ASA aminosalicylate, ECG electrocardiography, PCA posterior cerebral artery, ACA anterior cerebral artery