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

NCT ID: NCT07263308

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-08
• Study Completion Date: 2027-12-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Albumin combined with endovascular treatment group

Albumin combined with recommended endovascular treatment will be applied.

Group Type: EXPERIMENTAL

Albumin

Intervention Type: DRUG

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 treatment

Intervention Type: PROCEDURE

Best endovascular treatment.

Endovascular treatment group

Recommended endovascular treatment will be applied.

Group Type: ACTIVE_COMPARATOR

Endovascular treatment

Intervention Type: PROCEDURE

Best endovascular treatment.

Interventions

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.

Intervention Type: DRUG

Endovascular treatment

Best endovascular treatment.

Intervention Type: PROCEDURE

Eligibility Criteria

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 ≤1 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Professor of Neurology, Xuanwu Hospital, Capital Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taihe County Hospital of Traditional Chinese Medicine

Fuyang, Anhui, China

Site Status: RECRUITING

Si County People's Hospital

Suzhou, Anhui, China

Site Status: RECRUITING

Xuanwu Hospital，Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Shanghai General Hospital Jiujuan Hospital

Jiuquan, Gansu, China

Site Status: RECRUITING

Jixi People's Hospital

Jixi, Heilongjiang, China

Site Status: RECRUITING

Ningling County People's Hospital

Shangqiu, Henan, China

Site Status: RECRUITING

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

Site Status: NOT_YET_RECRUITING

Zhongmou County People's Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Rizhao Hospital of Traditional Chinese Medicine

Rizhao, Shandong, China

Site Status: RECRUITING

Laizhou People's Hospital

Yantai, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chuanjie Wu, MD

Role: CONTACT

wuchuanjie@ccmu.edu.cn

010-83199439

Facility Contacts

Zongtao Liu

Role: primary

Lei Shi

Role: primary

Chuanjie Wu, MD

Role: primary

wuchuanjie@ccmu.edu.cn

010-83199439

Kai Guo

Role: primary

Hongshan Cui

Role: primary

Xiaoyin Liu

Role: primary

Lingling Meng

Role: primary

Dongcheng Xu

Role: primary

Lihua Liu

Role: primary

Other Identifiers

ARISE-2

Identifier Type: -

Identifier Source: org_study_id