Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2
ARISE-2
1 other identifier
interventional
1,192
1 country
56
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2025
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2025
CompletedFirst Posted
Study publicly available on registry
December 4, 2025
CompletedStudy Start
First participant enrolled
December 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
September 9, 2026
April 1, 2026
1.5 years
November 23, 2025
September 8, 2026
Conditions
Keywords
Outcome Measures
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)
90 days
Secondary Outcomes (6)
Distribution of mRS scores
90 days and 1 year
Proportion of patients with mRS score 0-1
90 days and 1 year
24h National Institutes of Health Stroke Scale (NIHSS)
24 hours
National Institutes of Health Stroke Scale (NIHSS) at 7 days
7 days
EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)
90 days and 1 year
- +1 more secondary outcomes
Other Outcomes (5)
The incidence of symptomatic intracerebral hemorrhage
7 days
The incidence of newly onset atrial fibrillation within 7 days
7 days
The incidence rate of newly onset pulmonary edema or congestive heart failure within 7 days
7 days
- +2 more other outcomes
Study Arms (2)
Albumin combined with endovascular treatment group
EXPERIMENTALAlbumin combined with recommended endovascular treatment will be applied.
Endovascular treatment group
ACTIVE COMPARATORRecommended endovascular treatment will be applied.
Interventions
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.
Best endovascular treatment.
Eligibility Criteria
You may qualify if:
- Age between 18 and 80 years;
- Acute ischemic stroke with indications for endovascular treatment within 24 hours of onset;
- 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;
- National Institute of Health Stroke Scale (NIHSS) score \>=6;
- Alberta Stroke Program Early CT Score (ASPECTS) \>=3 points;
- Modified Rankin Scale (mRS) score ≤4 before onset of the disease;
- Written informed consent provided by the patients or their legal relatives.
You may not qualify if:
- 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;
- History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc;
- Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
- Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
- Pregnancy, breastfeeding;
- An episode or exacerbation of congestive heart failure from any cause in the past 6 months;
- History of heart valve disease complicated by congestive heart failure within the past 6 months;
- Cardiac surgery with thoracotomy (eg. coronary artery bypass grafting or valve replacement surgery) within the past 6 months;
- Acute myocardial infarction in the past 6 months;
- Signs or symptoms of acute myocardial infarction upon admission, including electrocardiographic findings;
- Elevated serum troponin concentration upon admission (\>0.1 μg/L) ;
- Acute arrhythmia (including any tachycardia or bradycardia) with hemodynamic instability (systolic blood pressure \<100 mm Hg) upon admission;
- Acute or chronic lung diseases requiring long-term or intermittent oxygen therapy;
- 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;
- Severe chronic anemia (hemoglobin \< 75 g/L);
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Susong County Hospital of Traditional Chinese Medicine
Anqing, Anhui, 246501, China
Bozhou People's Hospital
Bozhou, Anhui, 236800, China
Taihe County Hospital of Traditional Chinese Medicine
Fuyang, Anhui, China
Ma'anshan People's Hospital
Ma’anshan, Anhui, 243000, China
Si County People's Hospital
Suzhou, Anhui, China
Wuwei People's Hospital
Wuhu, Anhui, 238300, China
Wuhu Second People's Hospital
Wuhu, Anhui, 241000, China
Xuanwu Hospital，Capital Medical University
Beijing, Beijing Municipality, 100053, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Zhangzhou Hospital
Zhangzhou, Fujian, 363000, China
Shanghai General Hospital Jiujuan Hospital
Jiuquan, Gansu, China
PLA Joint Logistic Support Force 940th Hospital
Lanzhou, Gansu, 730050, China
Gansu Provincial Hospital
Lanzhou, Gansu, China
Sanshui Hospital of Zhujiang Hospital, Southern Medical University
Foshan, Guangdong, 528100, China
Heyuan People's Hospital
Heyuan, Guangdong, 517000, China
Huazhou People's Hospital
Huazhou, Guangdong, 525100, China
Huiyang Sanhe Hospital
Huizhou, Guangdong, 516211, China
Luoding People's Hospital
Luoyang, Guangdong, 527200, China
Cenxi People's Hospital
Cenxi, Guangxi, 543200, China
Guiyang Fourth People's Hospital
Guiyang, Guizhou, 550002, China
Baoding No. 1 Central Hospital
Baoding, Hebei, 071000, China
Kailuan General Hospital Linxi Hospital
Tangshan, Hebei, 063100, China
Jiamusi University Hongda Hospital
Jiamusi, Heilongjiang, 154000, China
Jixi People's Hospital
Jixi, Heilongjiang, China
Luoyang Central Hospital
Luoyang, Henan, 471000, China
Pingdingshan Second People's Hospital
Pingdingshan, Henan, 467000, China
Ningling County People's Hospital
Shangqiu, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Weihui, Henan, China
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan, 450007, China
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
Zhongmou County People's Hospital
Zhengzhou, Henan, China
Zhoukou Central Hospital
Zhoukou, Henan, 466000, China
Shenqiu County People's Hospital
Zhoukou, Henan, 466300, China
Xihua County People's Hospital
Zhoukou, Henan, 466600, China
Taihe Hospital, Hubei University of Medicine
Shiyan, Hubei, 442000, China
Tianmen First People's Hospital
Tianmen, Hubei, 431700, China
Changde First People's Hospital
Changde, Hunan, 415000, China
Liuyang Jili Hospital
Guankou, Hunan, 410300, China
The First Affiliated Hospital of Shaoyang University
Shaoyang, Hunan, 422000, China
Yiyang Central Hospital
Yiyang, Hunan, 413000, China
Xuzhou Cancer Hospital
Xuzhou, Jiangsu, 221005, China
Daliuta Experimental Area Hospital of Shenmu City
Shenmu, Shaanxi, 719315, China
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, 712000, China
Feicheng Hospital of Shandong Yiyang Health Group
Feicheng, Shandong, 271608, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250011, China
Linyi People's Hospital
Linyi, Shandong, 276000, China
Rizhao Hospital of Traditional Chinese Medicine
Rizhao, Shandong, China
PLA Joint Logistic Support Force 970th Hospital
Yantai, Shandong, 264000, China
Laizhou People's Hospital
Yantai, Shandong, China
Yiyuan County People's Hospital
Zibo, Shandong, 256100, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000, China
Meishan Second People's Hospital
Meishan, Sichuan, 620500, China
Donggang Central Hospital
Nanchong, Sichuan, 637300, China
People's Hospital of Bortala Mongol Autonomous Prefecture
Bole, Xinjiang, 833400, China
People's Hospital of Bayingolin Mongolian Autonomous Prefecture
Korla, Xinjiang, 841000, China
Huize County People's Hospital
Qujing, Yunnan, 654200, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology, Xuanwu Hospital, Capital Medical University
Study Record Dates
First Submitted
November 23, 2025
First Posted
December 4, 2025
Study Start
December 18, 2025
Primary Completion (Estimated)
June 20, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
September 9, 2026
Record last verified: 2026-04