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Acute Ischemic StrokePhase 3ARISE-2NCT07263308

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

A Phase 3 study testing Albumin and Endovascular treatment in people with Acute Ischemic Stroke, run by Capital Medical University at 61 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Albumin and Endovascular treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,192 participants
Where
61 sitesChina
Study dates
18 Dec 2025to 1 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 23Show fewer
  • 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);
  • Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 60 mL/min;
  • Refractory hypertension that is difficult to control by medication (defined as systolic blood pressure > 220 mmHg, or diastolic blood pressure > 110 mmHg);
  • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is greater than 1.5 times the upper limit of the normal value.
  • History of albumin allergy or known allergy to albumin;
  • Patients with severe mental disorders or dementia who are unable to cooperate in completing informed consent and follow-up content;
  • The expected survival time is less than 90 days (such as comorbidity with malignant tumor or severe systemic diseases etc.);
  • Patients who have participated in other interventional clinical studies within 30 days before randomization or are currently participating in other interventional clinical studies.
  • The investigator believes that the subject has other conditions making it unsuitable for participating in this study.

Trial locations and contacts

61 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chuanjie Wu, MD contact

010-83199439

wuchuanjie@ccmu.edu.cn

61 sites in 1 country

China61 sites, 61 recruiting
  • Susong County Hospital of Traditional Chinese Medicine

    Anqing, Anhui, 246501

    Xiang Ye, 13966942372, 810535994@qq.com

    Recruiting
  • Baoding No. 1 Central Hospital

    Baoding, Hebei, 071000

    Xueyan Zhang, 18617789559, 810535994@qq.com

    Recruiting
  • Xuanwu Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100053

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

    Recruiting
  • People's Hospital of Bortala Mongol Autonomous Prefecture

    Bole, Xinjiang, 833400

    Xinchen Zhang, 18509000802, 810535994@qq.com

    Recruiting
  • Bozhou People's Hospital

    Bozhou, Anhui, 236800

    Bin Zhang, 18756727809, 810535994@qq.com

    Recruiting
  • Cenxi People's Hospital

    Cenxi, Guangxi, 543200

    Mengguo Xu, 15277467773, 810535994@qq.com

    Recruiting
  • Changde First People's Hospital

    Changde, Hunan, 415000

    Ji Liang, 18627638086, 810535994@qq.com

    Recruiting
  • Changzhou Fourth People's Hospital

    Changzhou, Jiangsu, 213022

    Hanyan Xiao, 18861245553, 810535994@qq.com

    Recruiting
  • Dongguan People's Hospital

    Dongguan, Guangdong, 523000

    Genpei Luo, 13412332332, 810535994@qq.com

    Recruiting
  • Dongguan Eastern Central Hospital

    Dongguan, Guangdong, 523573

    QianRu Wen, 13751381385, 810535994@qq.com

    Recruiting
  • Feicheng Hospital of Shandong Yiyang Health Group

    Feicheng, Shandong, 271608

    Chuanliang Chang, 13792115105, 810535994@qq.com

    Recruiting
  • Sanshui Hospital of Zhujiang Hospital, Southern Medical University

    Foshan, Guangdong, 528100

    Menglu Dong, 15319291799, 810535994@qq.com

    Recruiting
  • Taihe County Hospital of Traditional Chinese Medicine

    Fuyang, Anhui

    Zongtao Liu

    Recruiting
  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Wenhuo Chen, 18120975204, 810535994@qq.com

    Recruiting
  • Liuyang Jili Hospital

    Guankou, Hunan, 410300

    Yuzhang Bei, 13723865335, 810535994@qq.com

    Recruiting
  • Guiyang Fourth People's Hospital

    Guiyang, Guizhou, 550002

    Hanyan Xiao, 18861245553, 810535994@qq.com

    Recruiting
  • Heyuan People's Hospital

    Heyuan, Guangdong, 517000

    Guanghong Zhong, 13825389399, 810535994@qq.com

    Recruiting
  • Huazhou People's Hospital

    Huazhou, Guangdong, 525100

    Yanbo Huang, 18000926351, 810535994@qq.com

    Recruiting
  • Huiyang Sanhe Hospital

    Huizhou, Guangdong, 516211

    Minglei Huang, 17817161595, 810535994@qq.com

    Recruiting
  • Jiamusi University Hongda Hospital

    Jiamusi, Heilongjiang, 154000

    Changsi Ai, 19845080777, 810535994@qq.com

    Recruiting
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    Jinan, Shandong, 250011

    Jinping Zhang, 15621868933, 810535994@qq.com

    Recruiting
  • Shanghai General Hospital Jiuquan Hospital

    Jiuquan, Gansu

    Kai Guo

    Recruiting
  • Jixi People's Hospital

    Jixi, Heilongjiang

    Hongshan Cui

    Recruiting
  • People's Hospital of Bayingolin Mongolian Autonomous Prefecture

    Korla, Xinjiang, 841000

    Liang Zhang, 15899014909, 810535994@qq.com

    Recruiting
  • PLA Joint Logistic Support Force 940th Hospital

    Lanzhou, Gansu, 730050

    Xiaoyan Zhang, 13893113576, 810535994@qq.com

    Recruiting
  • Gansu Provincial Hospital

    Lanzhou, Gansu

    Qian Liu, MD

    Recruiting
  • Linyi People's Hospital

    Linyi, Shandong, 276000

    Hao Wang, 18203923762, 810535994@qq.com

    Recruiting
  • Luoding People's Hospital

    Luoyang, Guangdong, 527200

    Wenzhi Chen, 13826778616, 810535994@qq.com

    Recruiting
  • Luoyang Central Hospital

    Luoyang, Henan, 471000

    Wenbo Li, 15136495590, 810535994@qq.com

    Recruiting
  • Ma'anshan People's Hospital

    Ma’anshan, Anhui, 243000

    Liang Xu, 18755509881, 810535994@qq.com

    Recruiting
  • Meishan Second People's Hospital

    Meishan, Sichuan, 620500

    Juan Zhou, 15282329169, 810535994@qq.com

    Recruiting
  • Sichuan Science City Hospital

    Mianyang, Sichuan, 621999

    Yuqi Peng, 15881623000, 810535994@qq.com

    Recruiting
  • Nanbu County People's Hospital

    Nanbu County, Sichuan, 637300

    Yi Tu, 18381759017, 810535994@qq.com

    Recruiting
  • Donggang Central Hospital

    Nanchong, Sichuan, 637300

    Yi Tu, 18381759017, 810535994@qq.com

    Recruiting
  • Nanyang First People's Hospital

    Nanyang, Henan, 473000

    Kan Li, 15937755331, 810535994@qq.com

    Recruiting
  • Pingdingshan Second People's Hospital

    Pingdingshan, Henan, 467000

    Yankuo Wang, 15537598608, 810535994@qq.com

    Recruiting
  • Huize County People's Hospital

    Qujing, Yunnan, 654200

    Yingming Zhao, 15187846226, 810535994@qq.com

    Recruiting
  • Rizhao Hospital of Traditional Chinese Medicine

    Rizhao, Shandong

    Dongcheng Xu

    Recruiting
  • Ningling County People's Hospital

    Shangqiu, Henan

    Xiaoyin Liu

    Recruiting
  • The First Affiliated Hospital of Shaoyang University

    Shaoyang, Hunan, 422000

    Songlin Tang, 15973277818, 810535994@qq.com

    Recruiting
  • Daliuta Experimental Area Hospital of Shenmu City

    Shenmu, Shaanxi, 719315

    Guoyu Wang, 13051135153, 810535994@qq.com

    Recruiting
  • Taihe Hospital, Hubei University of Medicine

    Shiyan, Hubei, 442000

    Gongwen Lei, 18372608915, 810535994@qq.com

    Recruiting
  • Si County People's Hospital

    Suzhou, Anhui

    Lei Shi

    Recruiting
  • Kailuan General Hospital Linxi Hospital

    Tangshan, Hebei, 063100

    Zhixian Liu, 15133973828, 810535994@qq.com

    Recruiting
  • Tianmen First People's Hospital

    Tianmen, Hubei, 431700

    Xuan Huang, 15114397199, 810535994@qq.com

    Recruiting
  • The First Affiliated Hospital of Xinxiang Medical University

    Weihui, Henan

    Hongkai Cui

    Recruiting
  • Wuwei People's Hospital

    Wuhu, Anhui, 238300

    Shucheng Wang, 13956637770, 810535994@qq.com

    Recruiting
  • Wuhu Second People's Hospital

    Wuhu, Anhui, 241000

    Lei Wang, 13965199096, 810535994@qq.com

    Recruiting
  • Yan'an University Xianyang Hospital

    Xianyang, Shaanxi, 712000

    Xiongfei Zhao, 18740505535, 810535994@qq.com

    Recruiting
  • Xuzhou Cancer Hospital

    Xuzhou, Jiangsu, 221005

    Kejun Zhang, 15190671097, 810535994@qq.com

    Recruiting
  • PLA Joint Logistic Support Force 970th Hospital

    Yantai, Shandong, 264000

    Rong Wang, 15965138998, 810535994@qq.com

    Recruiting
  • Laizhou People's Hospital

    Yantai, Shandong

    Lihua Liu

    Recruiting
  • Yiyang Central Hospital

    Yiyang, Hunan, 413000

    Jun Li, 15173799068, 810535994@qq.com

    Recruiting
  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044000

    Bin Wang, 18935096701, 810535994@qq.com

    Recruiting
  • Zhangzhou Hospital

    Zhangzhou, Fujian, 363000

    Jingyu Chen, 18759639196, 810535994@qq.com

    Recruiting
  • Zhengzhou Central Hospital Affiliated to Zhengzhou University

    Zhengzhou, Henan, 450007

    Dongpu Ma, 15290878649, 810535994@qq.com

    Recruiting
  • Zhongmou County People's Hospital

    Zhengzhou, Henan

    Lingling Meng

    Recruiting
  • Zhoukou Central Hospital

    Zhoukou, Henan, 466000

    Xinshan Yue, 17739588636, 810535994@qq.com

    Recruiting
  • Shenqiu County People's Hospital

    Zhoukou, Henan, 466300

    Yanling Li, 18736211234, 810535994@qq.com

    Recruiting
  • Xihua County People's Hospital

    Zhoukou, Henan, 466600

    Chaoqun Li, 18538625120, 810535994@qq.com

    Recruiting
  • Yiyuan County People's Hospital

    Zibo, Shandong, 256100

    Xiaofeng Tang, 13723990608, 810535994@qq.com

    Recruiting

Other trials in China

About this study

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.

Being tested
Albumin, Endovascular treatment
Keywords
Albumin, Acute Large Vessel Occlusive Stroke, Acute Ischemic Stroke, Endovascular Therapy, China
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlbuminDrug

    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.

  • Endovascular treatmentProcedure or surgery

    Best endovascular treatment.

Study groups in NCT07263308
Study groupRoleWhat they receive
Albumin combined with endovascular treatment groupExperimentalAlbumin combined with recommended endovascular treatment will be applied.
Receives: Drug: Albumin; Procedure: Endovascular treatment
Endovascular treatment groupActive comparatorRecommended endovascular treatment will be applied.
Receives: Procedure: Endovascular treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 90 days

Secondary outcomes (6)
  1. Distribution of mRS scores

    Measured: 90 days and 1 year

  2. Proportion of patients with mRS score 0-1

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 90 days and 1 year

  6. Proportion of Barthel Index (BI) ≥95

    Measured: 90 days and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2025
  2. Study start18 Dec 2025
  3. Primary completion20 Jun 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07263308
Sponsor's protocol ID
ARISE-2
Acronym
ARISE-2
Status last verified
Apr 2026
First submitted
23 Nov 2025
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Xu Z, Liu Y, Huang Y, Bei Y, He Y, Li Y, Wang H, Meng L, Gao L, Li Y, Cao Y, Liu L, Li J, Ji X, Wu C. Albumin for patients with acute large vessel occlusive stroke undergoing endovascular therapy-2 (ARISE-2): protocol for a randomised controlled trial. Eur Stroke J. 2026 Oct 5;11(10):aakag119. doi: 10.1093/esj/aakag119.

    PubMed 42831671

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Albumin and Endovascular treatment in people with Acute Ischemic Stroke, run by Capital Medical University at 61 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chuanjie Wu, MD (010-83199439, wuchuanjie@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07263308, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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