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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
61 sites in 1 country
China61 sites, 61 recruiting
- 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
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.
- Conditions
- Acute Ischemic Stroke
- 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 group | Role | What they receive |
|---|---|---|
| Albumin combined with endovascular treatment group | Experimental | Albumin combined with recommended endovascular treatment will be applied. Receives: Drug: Albumin; Procedure: Endovascular treatment |
| Endovascular treatment group | Active comparator | Recommended 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.
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)
Distribution of mRS scores
Measured: 90 days and 1 year
Proportion of patients with mRS score 0-1
Measured: 90 days and 1 year
24h National Institutes of Health Stroke Scale (NIHSS)
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.
Measured: 24 hours
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
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
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.
- First posted4 Dec 2025
- Study start18 Dec 2025
- Primary completion20 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2
- ClinicalTrials.gov ID
- NCT07263308
- Acronym / sponsor ID
- ARISE-2 / ARISE-2
- Conditions
- Acute Ischemic Stroke
- Keywords
- Albumin, Acute Large Vessel Occlusive Stroke, Acute Ischemic Stroke, Endovascular Therapy, China
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,192 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin combined with endovascular treatment group | Experimental | Drug: Albumin, Procedure: Endovascular treatmentAlbumin combined with recommended endovascular treatment will be applied. |
| Endovascular treatment group | Active comparator | Procedure: Endovascular treatmentRecommended endovascular treatment will be applied. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin25% 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. | Drug | Albumin combined with endovascular treatment group |
| Endovascular treatmentBest endovascular treatment. | Procedure or surgery | Albumin combined with endovascular treatment group, Endovascular treatment group |
Primary outcome
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)
6 secondary outcomes
Distribution of mRS scores
Time frame: 90 days and 1 year
Proportion of patients with mRS score 0-1
Time frame: 90 days and 1 year
24h National Institutes of Health Stroke Scale (NIHSS)
Time frame: 24 hours
National Institutes of Health Stroke Scale (NIHSS) at 7 days
Time frame: 7 days
EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)
Time frame: 90 days and 1 year
Proportion of Barthel Index (BI) ≥95
Time frame: 90 days and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 42831671Xu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
61 sites in 1 country: see every site and its status.
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.