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

September 8, 2026 updated by: Ji Xunming,MD,PhD, Capital Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

1192

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Anqing, Anhui, China, 246501
        • Recruiting
        • Susong County Hospital of Traditional Chinese Medicine
        • Contact:
      • Bozhou, Anhui, China, 236800
        • Recruiting
        • Bozhou People's Hospital
        • Contact:
      • Fuyang, Anhui, China
        • Recruiting
        • Taihe County Hospital of Traditional Chinese Medicine
        • Contact:
          • Zongtao Liu
      • Ma’anshan, Anhui, China, 243000
        • Recruiting
        • Ma'anshan People's Hospital
        • Contact:
      • Suzhou, Anhui, China
        • Recruiting
        • Si County People's Hospital
        • Contact:
          • Lei Shi
      • Wuhu, Anhui, China, 238300
        • Recruiting
        • Wuwei People's Hospital
        • Contact:
      • Wuhu, Anhui, China, 241000
        • Recruiting
        • Wuhu Second People's Hospital
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Recruiting
        • Xuanwu Hospital，Capital Medical University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Zhangzhou, Fujian, China, 363000
        • Recruiting
        • Zhangzhou Hospital
        • Contact:
    • Gansu
      • Jiuquan, Gansu, China
        • Recruiting
        • Shanghai General Hospital Jiujuan Hospital
        • Contact:
          • Kai Guo
      • Lanzhou, Gansu, China
        • Recruiting
        • Gansu Provincial Hospital
        • Contact:
          • Qian Liu, MD
      • Lanzhou, Gansu, China, 730050
        • Recruiting
        • PLA Joint Logistic Support Force 940th Hospital
        • Contact:
    • Guangdong
      • Foshan, Guangdong, China, 528100
        • Recruiting
        • Sanshui Hospital of Zhujiang Hospital, Southern Medical University
        • Contact:
      • Heyuan, Guangdong, China, 517000
        • Recruiting
        • Heyuan People's Hospital
        • Contact:
      • Huazhou, Guangdong, China, 525100
        • Recruiting
        • Huazhou People's Hospital
        • Contact:
      • Huizhou, Guangdong, China, 516211
        • Recruiting
        • Huiyang Sanhe Hospital
        • Contact:
      • Luoyang, Guangdong, China, 527200
        • Recruiting
        • Luoding People's Hospital
        • Contact:
    • Guangxi
      • Cenxi, Guangxi, China, 543200
        • Recruiting
        • Cenxi People's Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Recruiting
        • Guiyang Fourth People's Hospital
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 071000
        • Recruiting
        • Baoding No. 1 Central Hospital
        • Contact:
      • Tangshan, Hebei, China, 063100
        • Recruiting
        • Kailuan General Hospital Linxi Hospital
        • Contact:
    • Heilongjiang
      • Jiamusi, Heilongjiang, China, 154000
        • Recruiting
        • Jiamusi University Hongda Hospital
        • Contact:
      • Jixi, Heilongjiang, China
        • Recruiting
        • Jixi People's Hospital
        • Contact:
          • Hongshan Cui
    • Henan
      • Luoyang, Henan, China, 471000
        • Recruiting
        • Luoyang Central Hospital
        • Contact:
      • Pingdingshan, Henan, China, 467000
        • Recruiting
        • Pingdingshan Second People's Hospital
        • Contact:
      • Shangqiu, Henan, China
        • Recruiting
        • Ningling County People's Hospital
        • Contact:
          • Xiaoyin Liu
      • Weihui, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical University
        • Contact:
          • Hongkai Cui
      • Zhengzhou, Henan, China
        • Recruiting
        • Zhongmou County People's Hospital
        • Contact:
          • Lingling Meng
      • Zhengzhou, Henan, China, 450007
        • Recruiting
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Chinese Medicine
      • Zhoukou, Henan, China, 466000
        • Recruiting
        • Zhoukou Central Hospital
        • Contact:
      • Zhoukou, Henan, China, 466600
        • Recruiting
        • Xihua County People's Hospital
        • Contact:
      • Zhoukou, Henan, China, 466300
        • Recruiting
        • Shenqiu County People's Hospital
        • Contact:
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Recruiting
        • Taihe Hospital, Hubei University of Medicine
        • Contact:
      • Tianmen, Hubei, China, 431700
        • Recruiting
        • Tianmen First People's Hospital
        • Contact:
    • Hunan
      • Changde, Hunan, China, 415000
        • Recruiting
        • Changde First People's Hospital
        • Contact:
      • Guankou, Hunan, China, 410300
        • Recruiting
        • Liuyang Jili Hospital
        • Contact:
      • Shaoyang, Hunan, China, 422000
        • Recruiting
        • The First Affiliated Hospital of Shaoyang University
        • Contact:
      • Yiyang, Hunan, China, 413000
        • Recruiting
        • Yiyang Central Hospital
        • Contact:
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221005
        • Recruiting
        • Xuzhou Cancer Hospital
        • Contact:
    • Shaanxi
      • Shenmu, Shaanxi, China, 719315
        • Recruiting
        • Daliuta Experimental Area Hospital of Shenmu City
        • Contact:
      • Xianyang, Shaanxi, China, 712000
        • Recruiting
        • Yan'an University Xianyang Hospital
        • Contact:
    • Shandong
      • Feicheng, Shandong, China, 271608
        • Recruiting
        • Feicheng Hospital of Shandong Yiyang Health Group
        • Contact:
      • Jinan, Shandong, China, 250011
        • Recruiting
        • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
        • Contact:
      • Linyi, Shandong, China, 276000
        • Recruiting
        • Linyi People's Hospital
        • Contact:
      • Rizhao, Shandong, China
        • Recruiting
        • Rizhao Hospital of Traditional Chinese Medicine
        • Contact:
          • Dongcheng Xu
      • Yantai, Shandong, China
        • Recruiting
        • Laizhou People's Hospital
        • Contact:
          • Lihua Liu
      • Yantai, Shandong, China, 264000
        • Recruiting
        • PLA Joint Logistic Support Force 970th Hospital
        • Contact:
      • Zibo, Shandong, China, 256100
        • Recruiting
        • Yiyuan County People's Hospital
        • Contact:
    • Shanxi
      • Yuncheng, Shanxi, China, 044000
        • Recruiting
        • Yuncheng Central Hospital
        • Contact:
    • Sichuan
      • Meishan, Sichuan, China, 620500
        • Recruiting
        • Meishan Second People's Hospital
        • Contact:
      • Nanchong, Sichuan, China, 637300
        • Recruiting
        • Donggang Central Hospital
        • Contact:
    • Xinjiang
      • Bole, Xinjiang, China, 833400
        • Recruiting
        • People's Hospital of Bortala Mongol Autonomous Prefecture
        • Contact:
      • Korla, Xinjiang, China, 841000
        • Recruiting
        • People's Hospital of Bayingolin Mongolian Autonomous Prefecture
        • Contact:
    • Yunnan
      • Qujing, Yunnan, China, 654200
        • Recruiting
        • Huize County People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 and 80 years;
  2. Acute ischemic stroke with indications for endovascular treatment within 24 hours of onset;
  3. Anterior circulation acute ischemic stroke, with acute occlusion of the responsible vessel located in the intracranial segment of the internal carotid artery, or the M1 or 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 Criteria:

  1. Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan;
  2. History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc;
  3. Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
  4. Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
  5. Pregnancy, breastfeeding;
  6. An episode or exacerbation of congestive heart failure from any cause in the past 6 months;
  7. History of heart valve disease complicated by congestive heart failure within the past 6 months;
  8. Cardiac surgery with thoracotomy (eg. coronary artery bypass grafting or valve replacement 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, including electrocardiographic findings;
  11. Elevated serum troponin concentration upon admission (>0.1 μg/L) ;
  12. Acute arrhythmia (including any tachycardia or bradycardia) with hemodynamic instability (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) Jugular venous 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 of the lower extremities attributable to congestive heart failure or without apparent cause; (6) Rales in both lungs; (7) Or evidence of pulmonary edema, pleural effusion, 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 of normal, or estimated glomerular filtration rate (eGFR) < 60 mL/min;
  17. Refractory hypertension that is difficult to control by medication (defined as systolic blood pressure > 220 mmHg, or diastolic blood pressure > 110 mmHg);
  18. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is greater than 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 in completing informed consent and follow-up content;
  21. The expected survival time is less than 90 days (such as comorbidity with malignant tumor or severe systemic diseases etc.);
  22. Patients who have participated in other interventional clinical studies within 30 days before randomization or are currently participating in other interventional clinical studies.
  23. The investigator believes that the subject has other conditions making it unsuitable for participating in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Albumin combined with endovascular treatment group
Albumin combined with recommended endovascular treatment will be applied.
Drug: Albumin
25% human albumin at a dose of 0.5g/kg (maximum dose 37.5g) should be administered intravenously. On the second, third, and fourth days, 25% human albumin at a dose of 0.5g/kg (maximum dose 37.5g) should be administered daily.
Procedure: Endovascular treatment
Best endovascular treatment.
Active Comparator: Endovascular treatment group
Recommended endovascular treatment will be applied.
Procedure: Endovascular treatment
Best endovascular treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with mRS 0-2 or return to baseline mRS (if the baseline premorbid mRS =3-4) at 90 days.
Time Frame: 90 days
Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24h National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 24 hours
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.
24 hours
National Institutes of Health Stroke Scale (NIHSS) at 7 days
Time Frame: 7 days
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.
7 days
Distribution of mRS scores
Time Frame: 90 days and 1 year
90 days and 1 year
Proportion of patients with mRS score 0-1
Time Frame: 90 days and 1 year
90 days and 1 year
EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)
Time Frame: 90 days and 1 year
The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities,pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scoresindicating worse quality of life.
90 days and 1 year
Proportion of Barthel Index (BI) ≥95
Time Frame: 90 days and 1 year
90 days and 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of symptomatic intracerebral hemorrhage
Time Frame: 7 days
7 days
The incidence of newly onset atrial fibrillation within 7 days
Time Frame: 7 days
7 days
The incidence rate of newly onset pulmonary edema or congestive heart failure within 7 days
Time Frame: 7 days
7 days
All-cause mortality rate
Time Frame: 90 days and 1 year
90 days and 1 year
Proportion of patients with mRS 0-2 or return to baseline mRS (if the baseline premorbid mRS =3-4)
Time Frame: 1 year
Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2025

Primary Completion (Estimated)

June 20, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 23, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Actual)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARISE-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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