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

Capital Medical University

Status and phase: Enrolling; Phase 3

Conditions: Acute Ischemic Stroke

Treatments: Procedure: Endovascular treatment; Drug: Albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT07263308

ARISE-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,192 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,192 participants in 2 patient groups

Albumin combined with endovascular treatment group

Experimental group

Description:

Albumin combined with recommended endovascular treatment will be applied.

Treatment:

Drug: Albumin

Procedure: Endovascular treatment

Endovascular treatment group

Active Comparator group

Description:

Recommended endovascular treatment will be applied.

Treatment:

Procedure: Endovascular treatment