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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2 (NCT07263308) is a Phase 3 interventional studying Acute Ischemic Stroke, sponsored by Capital Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Acute Ischemic Stroke, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 1,192 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form provided by the patients or their legal relatives. Who Should NOT Join This Trial: 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (12)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07263308), the sponsor (Capital Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07263308 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07263308?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07263308?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07263308. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07263308. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.