Albumin plus endovascular therapy for anterior large-vessel ischemic stroke

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

This trial will try adding albumin to endovascular treatment to see if it helps adults (18–80) with anterior large-vessel ischemic stroke treated within 24 hours.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1192 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Locations: 12 sites (Fuyang, Anhui and 11 other locations)
• Trial ID: NCT07263308 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, open-label, randomized phase 3 trial that assigns eligible patients 1:1 to either albumin combined with endovascular therapy or endovascular therapy alone. All participants receive standard acute stroke care and secondary prevention per guideline recommendations, and baseline CT or MR angiography, laboratory tests, NIHSS, ASPECTS, and mRS are recorded. The study focuses on safety and functional outcomes after reperfusion therapy for anterior circulation large‑vessel occlusions, with a 90-day telephone follow-up collecting quality‑of‑life and outcome scales. The trial aims to determine whether adding albumin improves recovery without unacceptable adverse effects.

Who should consider this trial

Good fit: Adults aged 18–80 with anterior circulation large‑vessel occlusion eligible for endovascular treatment within 24 hours, NIHSS ≥6, ASPECTS ≥3, premorbid mRS ≤4, and who (or whose legal representative) can provide written consent are ideal candidates.

Not a fit: Patients with evidence of intracranial hemorrhage, known bleeding or coagulation disorders, non‑anterior or small‑vessel strokes, presentation outside the treatment window, or other major contraindications may not receive benefit from this intervention.

Why it matters

Potential benefit: If successful, adding albumin could reduce disability and improve recovery after anterior large‑vessel occlusive stroke treated with endovascular therapy.

How similar studies have performed: Prior large trials of albumin in acute ischemic stroke (for example the ALIAS program) did not show clear overall benefit and raised safety concerns, so using albumin specifically with modern endovascular therapy is relatively novel and unproven.

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 ≤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.

Where this trial is running

Fuyang, Anhui and 11 other locations

• Taihe County Hospital of Traditional Chinese Medicine — Fuyang, Anhui, China (Recruiting)
• Si County People's Hospital — Suzhou, Anhui, China (Recruiting)
• Xuanwu Hospital，Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Shanghai General Hospital Jiujuan Hospital — Jiuquan, Gansu, China (Recruiting)
• Gansu Provincial Hospital — Lanzhou, Gansu, China (Recruiting)
• Jixi People's Hospital — Jixi, Heilongjiang, China (Recruiting)
• Ningling County People's Hospital — Shangqiu, Henan, China (Recruiting)
• The First Affiliated Hospital of Xinxiang Medical University — Weihui, Henan, China (Recruiting)
• The First Affiliated Hospital of Henan University of Chinese Medicine — Zhengzhou, Henan, China (Not_yet_recruiting)
• Zhongmou County People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Rizhao Hospital of Traditional Chinese Medicine — Rizhao, Shandong, China (Recruiting)
• Laizhou People's Hospital — Yantai, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Chuanjie Wu, MD

Conditions Acute Ischemic Stroke; Albumin; Acute Large Vessel Occlusive Stroke; Endovascular Therapy; China