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RecruitingNCT07263308ARISE-2Updated Sep 9, 2026

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

A Phase 3 interventional study of Albumin and Endovascular treatment in Acute Ischemic Stroke, sponsored by Capital Medical University. Recruiting at 56 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Capital Medical University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,192
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Acute Ischemic Stroke

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Keywords

  • Albumin
  • Acute Large Vessel Occlusive Stroke
  • Acute Ischemic Stroke
  • Endovascular Therapy
  • China
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,192 participants (estimated)

Study arms

  • Experimental
    Albumin combined with endovascular treatment group

    Albumin combined with recommended endovascular treatment will be applied.

    Drug: Albumin · Procedure: Endovascular treatment

  • Active comparator
    Endovascular treatment group

    Recommended endovascular treatment will be applied.

    Procedure: Endovascular treatment

Interventions

  • DrugAlbumin

    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.

  • ProcedureEndovascular treatment

    Best endovascular treatment.

05

What researchers measure

Primary outcomes

  1. Proportion of patients with mRS 0-2 or return to baseline mRS (if the baseline premorbid mRS =3-4) at 90 days.

    Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)

    Time frame: 90 days

Secondary outcomes

  1. Distribution of mRS scores

    Time frame: 90 days and 1 year

  2. Proportion of patients with mRS score 0-1

    Time frame: 90 days and 1 year

  3. 24h National Institutes of Health Stroke Scale (NIHSS)

    The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.

    Time frame: 24 hours

  4. National Institutes of Health Stroke Scale (NIHSS) at 7 days

    The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.

    Time frame: 7 days

  5. EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)

    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.

    Time frame: 90 days and 1 year

  6. Proportion of Barthel Index (BI) ≥95

    Time frame: 90 days and 1 year

Other outcomes

  1. The incidence of symptomatic intracerebral hemorrhage

    Time frame: 7 days

  2. The incidence of newly onset atrial fibrillation within 7 days

    Time frame: 7 days

  3. The incidence rate of newly onset pulmonary edema or congestive heart failure within 7 days

    Time frame: 7 days

  4. All-cause mortality rate

    Time frame: 90 days and 1 year

  5. Proportion of patients with mRS 0-2 or return to baseline mRS (if the baseline premorbid mRS =3-4)

    Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)

    Time frame: 1 year

06

Study locations

55 of 56 sites recruiting
  • Susong County Hospital of Traditional Chinese Medicine
    Anqing, Anhui 246501, China
    Recruiting
  • Bozhou People's Hospital
    Bozhou, Anhui 236800, China
    Recruiting
  • Taihe County Hospital of Traditional Chinese Medicine
    Fuyang, Anhui, China
    • Zongtao Liu · Contact
    Recruiting
  • Ma'anshan People's Hospital
    Ma’anshan, Anhui 243000, China
    Recruiting
  • Si County People's Hospital
    Suzhou, Anhui, China
    • Lei Shi · Contact
    Recruiting
  • Wuwei People's Hospital
    Wuhu, Anhui 238300, China
    Recruiting
  • Wuhu Second People's Hospital
    Wuhu, Anhui 241000, China
    Recruiting
  • Xuanwu Hospital,Capital Medical University
    Beijing, Beijing Municipality 100053, China
    Recruiting
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350001, China
    Recruiting
  • Zhangzhou Hospital
    Zhangzhou, Fujian 363000, China
    Recruiting
  • Shanghai General Hospital Jiujuan Hospital
    Jiuquan, Gansu, China
    • Kai Guo · Contact
    Recruiting
  • PLA Joint Logistic Support Force 940th Hospital
    Lanzhou, Gansu 730050, China
    Recruiting
  • Gansu Provincial Hospital
    Lanzhou, Gansu, China
    • Qian Liu, MD · Contact
    Recruiting
  • Sanshui Hospital of Zhujiang Hospital, Southern Medical University
    Foshan, Guangdong 528100, China
    Recruiting
  • Heyuan People's Hospital
    Heyuan, Guangdong 517000, China
    Recruiting
  • Huazhou People's Hospital
    Huazhou, Guangdong 525100, China
    Recruiting
  • Huiyang Sanhe Hospital
    Huizhou, Guangdong 516211, China
    Recruiting
  • Luoding People's Hospital
    Luoyang, Guangdong 527200, China
    Recruiting
  • Cenxi People's Hospital
    Cenxi, Guangxi 543200, China
    Recruiting
  • Guiyang Fourth People's Hospital
    Guiyang, Guizhou 550002, China
    Recruiting
  • Baoding No. 1 Central Hospital
    Baoding, Hebei 071000, China
    Recruiting
  • Kailuan General Hospital Linxi Hospital
    Tangshan, Hebei 063100, China
    Recruiting
  • Jiamusi University Hongda Hospital
    Jiamusi, Heilongjiang 154000, China
    Recruiting
  • Jixi People's Hospital
    Jixi, Heilongjiang, China
    • Hongshan Cui · Contact
    Recruiting
  • Luoyang Central Hospital
    Luoyang, Henan 471000, China
    Recruiting
  • Pingdingshan Second People's Hospital
    Pingdingshan, Henan 467000, China
    Recruiting
  • Ningling County People's Hospital
    Shangqiu, Henan, China
    • Xiaoyin Liu · Contact
    Recruiting
  • The First Affiliated Hospital of Xinxiang Medical University
    Weihui, Henan, China
    • Hongkai Cui · Contact
    Recruiting
  • Zhengzhou Central Hospital Affiliated to Zhengzhou University
    Zhengzhou, Henan 450007, China
    Recruiting
  • The First Affiliated Hospital of Henan University of Chinese Medicine
    Zhengzhou, Henan, China
    Not yet recruiting
  • Zhongmou County People's Hospital
    Zhengzhou, Henan, China
    • Lingling Meng · Contact
    Recruiting
  • Zhoukou Central Hospital
    Zhoukou, Henan 466000, China
    Recruiting
  • Shenqiu County People's Hospital
    Zhoukou, Henan 466300, China
    Recruiting
  • Xihua County People's Hospital
    Zhoukou, Henan 466600, China
    Recruiting
  • Taihe Hospital, Hubei University of Medicine
    Shiyan, Hubei 442000, China
    Recruiting
  • Tianmen First People's Hospital
    Tianmen, Hubei 431700, China
    Recruiting
  • Changde First People's Hospital
    Changde, Hunan 415000, China
    Recruiting
  • Liuyang Jili Hospital
    Guankou, Hunan 410300, China
    Recruiting
  • The First Affiliated Hospital of Shaoyang University
    Shaoyang, Hunan 422000, China
    Recruiting
  • Yiyang Central Hospital
    Yiyang, Hunan 413000, China
    Recruiting
  • Xuzhou Cancer Hospital
    Xuzhou, Jiangsu 221005, China
    Recruiting
  • Daliuta Experimental Area Hospital of Shenmu City
    Shenmu, Shaanxi 719315, China
    Recruiting
  • Yan'an University Xianyang Hospital
    Xianyang, Shaanxi 712000, China
    Recruiting
  • Feicheng Hospital of Shandong Yiyang Health Group
    Feicheng, Shandong 271608, China
    Recruiting
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
    Jinan, Shandong 250011, China
    Recruiting
  • Linyi People's Hospital
    Linyi, Shandong 276000, China
    Recruiting
  • Rizhao Hospital of Traditional Chinese Medicine
    Rizhao, Shandong, China
    • Dongcheng Xu · Contact
    Recruiting
  • PLA Joint Logistic Support Force 970th Hospital
    Yantai, Shandong 264000, China
    Recruiting
  • Laizhou People's Hospital
    Yantai, Shandong, China
    • Lihua Liu · Contact
    Recruiting
  • Yiyuan County People's Hospital
    Zibo, Shandong 256100, China
    Recruiting
  • Yuncheng Central Hospital
    Yuncheng, Shanxi 044000, China
    Recruiting
  • Meishan Second People's Hospital
    Meishan, Sichuan 620500, China
    Recruiting
  • Donggang Central Hospital
    Nanchong, Sichuan 637300, China
    Recruiting
  • People's Hospital of Bortala Mongol Autonomous Prefecture
    Bole, Xinjiang 833400, China
    Recruiting
  • People's Hospital of Bayingolin Mongolian Autonomous Prefecture
    Korla, Xinjiang 841000, China
    Recruiting
  • Huize County People's Hospital
    Qujing, Yunnan 654200, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07263308
Lead sponsor
Capital Medical University
Responsible party
Ji Xunming,MD,PhD (Professor of Neurology, Xuanwu Hospital, Capital Medical University, Capital Medical University) — Principal investigator
First posted
Dec 4, 2025
Start date
Dec 18, 2025
Primary completion
Jun 20, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Chuanjie Wu, MD
Contact
wuchuanjie@ccmu.edu.cn
010-83199439

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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