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

April 12, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Fuyang, Anhui, China
        • Recruiting
        • Taihe County Hospital of Traditional Chinese Medicine
        • Contact:
          • Zongtao Liu
      • Suzhou, Anhui, China
        • Recruiting
        • Si County People's Hospital
        • Contact:
          • Lei Shi
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Recruiting
        • Xuanwu Hospital，Capital Medical University
        • 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
    • Heilongjiang
      • Jixi, Heilongjiang, China
        • Recruiting
        • Jixi People's Hospital
        • Contact:
          • Hongshan Cui
    • Henan
      • 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
        • Not yet recruiting
        • the First Affiliated Hospital of Henan University of Chinese Medicine
    • Shandong
      • Rizhao, Shandong, China
        • Recruiting
        • Rizhao Hospital of Traditional Chinese Medicine
        • Contact:
          • Dongcheng Xu
      • Yantai, Shandong, China
        • Recruiting
        • Laizhou People's Hospital
        • Contact:
          • Lihua Liu

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with mRS score 0-1 at 90 days
Time Frame: 90 days
90 days
Distribution of mRS scores at 90 days
Time Frame: 90 days
90 days
Proportion of Barthel Index (BI) ≥95 at 90 days
Time Frame: 90 days
90 days
EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) at 90 days
Time Frame: 90 days
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
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
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 at 90 days
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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