Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2

Last updated: April 12, 2026
Sponsor: Capital Medical University
Overall Status: Active - Recruiting

Phase

3

Condition

Thrombosis

Cerebral Ischemia

Stroke

Treatment

Albumin

Endovascular treatment

Clinical Study ID

NCT07263308
ARISE-2
  • Ages 18-80
  • All Genders

Study Summary

This study is a prospective, multicenter, open-label, randomized controlled clinical trial. The investigators will apply albumin to the reperfusion treatment of patients with acute ischemic stroke in the anterior circulation. This study aims to verify the efficacy and safety of albumin combined with endovascular treatment in patients with anterior circulation acute ischemic stroke.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age between 18 and 80 years;

  2. Acute ischemic stroke with indications for endovascular treatment within 24 hours ofonset;

  3. Anterior circulation acute ischemic stroke, with acute occlusion of the responsiblevessel located in the intracranial segment of the internal carotid artery, or the M1or M2 segment of the middle cerebral artery;

  4. National Institute of Health Stroke Scale (NIHSS) score >=6;

  5. Alberta Stroke Program Early CT Score (ASPECTS) >=3 points;

  6. Modified Rankin Scale (mRS) score ≤4 before onset of the disease;

  7. Written informed consent provided by the patients or their legal relatives.

Exclusion

Exclusion Criteria:

  1. Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoidhemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) onthe baseline CT or MRI scan;

  2. History of congenital or acquired bleeding disorders, coagulation factor deficiencydiseases, thrombocytopenic diseases, etc;

  3. Anticipated difficulty in completing endovascular treatment due to vasculartortuosity;

  4. Known severe allergy (more severe than skin rash) to contrast agents uncontrolled bymedications;

  5. Pregnancy, breastfeeding;

  6. An episode or exacerbation of congestive heart failure from any cause in the past 6months;

  7. History of heart valve disease complicated by congestive heart failure within thepast 6 months;

  8. Cardiac surgery with thoracotomy (eg. coronary artery bypass grafting or valvereplacement surgery) within the past 6 months;

  9. Acute myocardial infarction in the past 6 months;

  10. Signs or symptoms of acute myocardial infarction upon admission, includingelectrocardiographic findings;

  11. Elevated serum troponin concentration upon admission (>0.1 μg/L) ;

  12. Acute arrhythmia (including any tachycardia or bradycardia) with hemodynamicinstability (systolic blood pressure <100 mm Hg) upon admission;

  13. Acute or chronic lung diseases requiring long-term or intermittent oxygen therapy;

  14. Findings on physical examination of any of the following abnormalities: (1) Jugularvenous distension (jugular venous pulsation >4 cm above the sternal angle); (2)Resting tachycardia due to congestive heart failure (heart rate > 100 per/min); (3)Third heart sound; (4) Abnormal hepatic jugular venous reflux; (5) Pitting edema ofthe lower extremities attributable to congestive heart failure or without apparentcause; (6) Rales in both lungs; (7) Or evidence of pulmonary edema, pleuraleffusion, or pulmonary vascular redistribution on chest X-ray;

  15. Severe chronic anemia (hemoglobin < 75 g/L);

  16. Known recent or current serum creatinine exceeding 1.5 times the upper limit ofnormal, or estimated glomerular filtration rate (eGFR) < 60 mL/min;

  17. Refractory hypertension that is difficult to control by medication (defined assystolic blood pressure > 220 mmHg, or diastolic blood pressure > 110 mmHg);

  18. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is greaterthan 1.5 times the upper limit of the normal value.

  19. History of albumin allergy or known allergy to albumin;

  20. Patients with severe mental disorders or dementia who are unable to cooperate incompleting informed consent and follow-up content;

  21. The expected survival time is less than 90 days (such as comorbidity with malignanttumor or severe systemic diseases etc.);

  22. Patients who have participated in other interventional clinical studies within 30days before randomization or are currently participating in other interventionalclinical studies.

  23. The investigator believes that the subject has other conditions making it unsuitablefor participating in this study.

Study Design

Total Participants: 1192
Treatment Group(s): 2
Primary Treatment: Albumin
Phase: 3
Study Start date:
December 18, 2025
Estimated Completion Date:
December 01, 2027

Study Description

This study investigates the application of albumin in reperfusion therapy for patients with acute ischemic stroke in the anterior circulation. Patients who met all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 ratio to either the Albumin combined with Endovascular Therapy group or the Endovascular Therapy group. All subjects in both groups received acute stroke treatment and secondary prevention therapy according to current American stroke guidelines, aside from our intervention. At baseline, subjects underwent non-contrast cranial computed tomography (CT) or magnetic resonance angiography (MRA) to identify the occlusion site and presence of hemorrhage; relevant laboratory tests and mRS, NIHSS, and ASPECTS scores were also completed. Furthermore, vital signs were recorded. A 90-day post-randomization telephone follow-up was conducted to assess patients using several quality of life scales.

Connect with a study center

  • Taihe County Hospital of Traditional Chinese Medicine

    Fuyang, Anhui
    China

    Active - Recruiting

  • Si County People's Hospital

    Suzhou, Anhui
    China

    Active - Recruiting

  • Taihe County Hospital of Traditional Chinese Medicine

    Fuyang 1810845, Anhui 1818058
    China

    Site Not Available

  • Si County People's Hospital

    Suzhou 1793743, Anhui 1818058
    China

    Site Not Available

  • Xuanwu Hospital,Capital Medical University

    Beijing, Beijing Municipality 100053
    China

    Active - Recruiting

  • Xuanwu Hospital,Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349 100053
    China

    Site Not Available

  • Shanghai General Hospital Jiujuan Hospital

    Jiuquan, Gansu
    China

    Active - Recruiting

  • Gansu Provincial Hospital

    Lanzhou, Gansu
    China

    Active - Recruiting

  • Shanghai General Hospital Jiujuan Hospital

    Jiuquan 1279945, Gansu 1810676
    China

    Site Not Available

  • Gansu Provincial Hospital

    Lanzhou 1804430, Gansu 1810676
    China

    Site Not Available

  • Jixi People's Hospital

    Jixi, Heilongjiang
    China

    Active - Recruiting

  • Jixi People's Hospital

    Jixi 2036389, Heilongjiang 2036965
    China

    Site Not Available

  • Ningling County People's Hospital

    Shangqiu, Henan
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Weihui, Henan
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Chinese Medicine

    Zhengzhou, Henan
    China

    Site Not Available

  • Zhongmou County People's Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Ningling County People's Hospital

    Shangqiu 1783934, Henan 1808520
    China

    Site Not Available

  • The First Affiliated Hospital of Xinxiang Medical University

    Weihui 1805031, Henan 1808520
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Chinese Medicine

    Zhengzhou 1784658, Henan 1808520
    China

    Site Not Available

  • Zhongmou County People's Hospital

    Zhengzhou 1784658, Henan 1808520
    China

    Active - Recruiting

  • Rizhao Hospital of Traditional Chinese Medicine

    Rizhao, Shandong
    China

    Active - Recruiting

  • Laizhou People's Hospital

    Yantai, Shandong
    China

    Active - Recruiting

  • Rizhao Hospital of Traditional Chinese Medicine

    Rizhao 9072919, Shandong 1796328
    China

    Site Not Available

  • Laizhou People's Hospital

    Yantai 1787093, Shandong 1796328
    China

    Site Not Available

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