Phase
Condition
Blood Clots
Stroke
Cerebral Ischemia
Treatment
N/AClinical Study ID
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults ≥19 years
Patients who were presented to hospitals after onset of brain ischemic symptoms fromthe base of last normal state and can start Endovascular therapy in accordance withstandard practice guidelines within 8 hours after the symptom onset.
NIHSS scores on screening time point (admission) ≥ 8 points
Patients whose activity is possible without the help of others in the gen-eralcondition one day before the ischemic stroke onset. and whose Barthel index scoresexceed 90 points
Patients whose brain CT and CT angiography imaging confirmed acute ischemic stroke andsymptomatic intracranial occlusion at screening and whose occlusion site consideredthe cause of acute ischemic stroke meets the following conditions:
① Carotid T or L type occlusion
② M1 MCA
③ M1-MCA equivalent (two or more M2-MCAs) However, anterior temporal artery is notregarded M2
Patients with ASPECTS on Brain CT without early imaging hyper-enhancement ≥ 6
Patients who spontaneously submitted a written informed consent to participation onthis clinical study
Exclusion
Exclusion Criteria:
a medical history of hypersensitivity against aspirin (salicylates), sulfasalazine or (5-ASA) at screening.
Patients who meets the exclusion criteria on imaging in intra-arterial re-canalizationtherapy ① CTA Patients whose imaging shows that the site of occlusion considered the cause of acuteischemic stroke meets the following conditions: A. MCA + PCA or MCA+ACA occlusion in Carotid T/L B. occlusion of a bilateral largeartery C. simultaneous infiltration of anterior and posterior circulation
② absence of the collateral circulation corresponding to one of the followings: A. OnCT angiography (MIP-CTA) imaging, absence or minimal collateral circulation at ≥50% ofMCA territories, compared with pial filling of contralateral side of the lesion.
- Patients whose heart diseases corresponding to following conditions were confirmed atscreening:
① Patients who were diagnosed with myocardial infarction within 6 months at screening
② Patients who had severe arrhythmia evoking clinical symptoms (respiratorydifficulties, tachycardia etc.) within 6 months at screening. Patients whose ECG measured at the stable state at emergency room confirmed thefollowing results: A. pulse rate < 50 or >120 beats per minute B. 2nd or 3rd degree AV block isconfirmed. C. congenital or acquired QT syndrome is confirmed D. ventricularpre-excitation syndrome is confirmed
- Patients who were diagnosed with heart failure ≥ class II according to "heart failureclassification by NYHA (New York Heart Association)" before screening.
"heart failure classification by NYHA (New York Heart Association)" Class I: patientswith no limitation of activities; they suffer no symptoms from ordinary activities. Class II: patients with slight, mild limitation of activity; they are comfortable withrest or with mild exertion. Class III: patients with marked limitation of activity; they are comfortable only atrest. Class IV: patients who should be at complete rest, confined to bed or chair; anyphysical activity brings on.
Patients who have contraindication to contrast media for brain imaging
Patients who are receiving renal replacement therapy such as dialysis, due to acute orchronic renal failure, nephropathy, etc. at screening.
Patients who were diagnosed with cancer or received cancer therapy within 6 months atscreening or have recurrent or transitional cancer
Patients who show high body temperature of 38℃ or more or who need antibiotic therapydue to medical opinion of infectious diseases at screening.
Patients who take pharmacotherapy due to liver diseases such as hepatitis, livercirrhosis etc. at screening.
Patients who are pregnant or lactating. However, in case of a woman of child-bearingpotential, only patients whose non-pregnancy was confirmed can participate in thisclinical study.
Patients who participated in other clinical studies within past 3 months at thescreening time as a base. However, in case of participation in an observatory studywithout medication, the patients can participate in this clinical study.
Patients who were determined unsuitable for participation in this clinical study dueto other reasons.
Study Design
Study Description
Connect with a study center
Chungbuk National University Hospital
Cheongju, 28644
Korea, Republic ofActive - Recruiting
Keimyung University Dongsan Medical Center
Daegu, 41931
Korea, Republic ofActive - Recruiting
Kyungpook National University Hospital
Daegu, 41944
Korea, Republic ofActive - Recruiting
Chosun University Hospital
Gwangju, 61453
Korea, Republic ofActive - Recruiting
Gachon University Gil Medical Center
Incheon, 21565
Korea, Republic ofActive - Recruiting
Ajou University Hospital
Seoul, 16499
Korea, Republic ofActive - Recruiting
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