NCT07263308

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,192

participants targeted

Target at P75+ for phase_3

Timeline
18mo left

Started Dec 2025

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

November 23, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

December 18, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

November 23, 2025

Last Update Submit

April 12, 2026

Conditions

Acute Ischemic Stroke

Keywords

AlbuminAcute Large Vessel Occlusive StrokeAcute Ischemic StrokeEndovascular TherapyChina

Outcome Measures

Primary Outcomes (1)

  • 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)

    90 days

Secondary Outcomes (6)

  • Distribution of mRS scores at 90 days

    90 days

  • Proportion of patients with mRS score 0-1 at 90 days

    90 days

  • 24h National Institutes of Health Stroke Scale (NIHSS)

    24 hours

  • National Institutes of Health Stroke Scale (NIHSS) at 7 days

    7 days

  • EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) at 90 days

    90 days

  • +1 more secondary outcomes

Other Outcomes (4)

  • The incidence of symptomatic intracerebral hemorrhage

    7 days

  • The incidence of newly onset atrial fibrillation within 7 days

    7 days

  • The incidence rate of newly onset pulmonary edema or congestive heart failure within 7 days

    7 days

  • +1 more other outcomes

Study Arms (2)

Albumin combined with endovascular treatment group

EXPERIMENTAL

Albumin combined with recommended endovascular treatment will be applied.

Drug: AlbuminProcedure: Endovascular treatment

Endovascular treatment group

ACTIVE COMPARATOR

Recommended endovascular treatment will be applied.

Procedure: Endovascular treatment

Interventions

AlbuminDRUG

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.

Albumin combined with endovascular treatment group
Endovascular treatmentPROCEDURE

Best endovascular treatment.

Albumin combined with endovascular treatment groupEndovascular treatment group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80 years;
  • Acute ischemic stroke with indications for endovascular treatment within 24 hours of onset;
  • 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;
  • National Institute of Health Stroke Scale (NIHSS) score \>=6;
  • Alberta Stroke Program Early CT Score (ASPECTS) \>=3 points;
  • Modified Rankin Scale (mRS) score ≤4 before onset of the disease;
  • Written informed consent provided by the patients or their legal relatives.

You may not qualify if:

  • 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;
  • History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc;
  • Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
  • Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
  • Pregnancy, breastfeeding;
  • An episode or exacerbation of congestive heart failure from any cause in the past 6 months;
  • History of heart valve disease complicated by congestive heart failure within the past 6 months;
  • Cardiac surgery with thoracotomy (eg. coronary artery bypass grafting or valve replacement surgery) within the past 6 months;
  • Acute myocardial infarction in the past 6 months;
  • Signs or symptoms of acute myocardial infarction upon admission, including electrocardiographic findings;
  • Elevated serum troponin concentration upon admission (\>0.1 μg/L) ;
  • Acute arrhythmia (including any tachycardia or bradycardia) with hemodynamic instability (systolic blood pressure \<100 mm Hg) upon admission;
  • Acute or chronic lung diseases requiring long-term or intermittent oxygen therapy;
  • 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;
  • Severe chronic anemia (hemoglobin \< 75 g/L);
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

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, 100053, 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

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Albumins

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Central Study Contacts

Chuanjie Wu, MD

CONTACT

010-83199439wuchuanjie@ccmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology, Xuanwu Hospital, Capital Medical University

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 4, 2025

Study Start

December 18, 2025

Primary Completion (Estimated)

June 20, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

CN(12)