A Phase 3 interventional study of Albumin and Endovascular treatment in Acute Ischemic Stroke, sponsored by Capital Medical University. Recruiting at 56 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Capital Medical University · Phase 3, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Albumin combined with recommended endovascular treatment will be applied.
Drug: Albumin · Procedure: Endovascular treatment
Recommended endovascular treatment will be applied.
Procedure: Endovascular treatment
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.
Best endovascular treatment.
Proportion of patients with mRS 0-2 or return to baseline mRS (if the baseline premorbid mRS =3-4) at 90 days.
Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)
Time frame: 90 days
Distribution of mRS scores
Time frame: 90 days and 1 year
Proportion of patients with mRS score 0-1
Time frame: 90 days and 1 year
24h National Institutes of Health Stroke Scale (NIHSS)
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.
Time frame: 24 hours
National Institutes of Health Stroke Scale (NIHSS) at 7 days
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.
Time frame: 7 days
EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)
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.
Time frame: 90 days and 1 year
Proportion of Barthel Index (BI) ≥95
Time frame: 90 days and 1 year
The incidence of symptomatic intracerebral hemorrhage
Time frame: 7 days
The incidence of newly onset atrial fibrillation within 7 days
Time frame: 7 days
The incidence rate of newly onset pulmonary edema or congestive heart failure within 7 days
Time frame: 7 days
All-cause mortality rate
Time frame: 90 days and 1 year
Proportion of patients with mRS 0-2 or return to baseline mRS (if the baseline premorbid mRS =3-4)
Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)
Time frame: 1 year
Plan to share: Undecided
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Capital Medical University