Acute Ischemic StrokePhase 2NCT06538844
Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Reperfusion Therapy
A Phase 2 study testing Intravenous infusion of human albumin and Saline in people with Acute Ischemic Stroke, run by Capital Medical University at 8 sites in China.
Trial summary
The objective of this study is to evaluate the effectiveness and safety of endovascular therapy combined with 25% human albumin in the treatment of acute large vessel occlusive stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Intravenous infusion of human albumin and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 8 sitesChina
- Study dates
- 10 Aug 2024to 15 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years;
- 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;
- Modified Rankin Scale (mRS) score ≤1 before onset of the disease;
- Alberta Stroke Program Early CT Score (ASPECTS) ≥3 points;
- Ischemic-core volume ≤100ml;
- Patient treatable within 24 hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline) if patients are unable to provide a reliable history or the point in time when symptoms have started if patients can provide a reliable history. Treatment start is defined as groin puncture.;
- Written informed consent provided by the patients or their legal relatives.
Who cannot join
- 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;
Show all 21Show fewer
- 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；
- Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 60 mL/min;
- Refractory hypertension that is difficult to control by medication (defined as systolic blood pressure > 220 mmHg, or diastolic blood pressure > 110 mmHg);
- Severe chronic anemia (hemoglobin < 75 g/L);
- History of albumin allergy or known allergy to albumin;
- Patients with severe mental disorders or dementia who are unable to cooperate in completing informed consent and follow-up content;
- The expected survival time is less than 90 days (such as comorbidity with malignant tumor or severe systemic diseases etc.);
- Patients who have participated in other interventional clinical studies within 30 days prior to randomization or are currently participating in other interventional clinical studies.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Liaocheng Third People's Hospital
Liaocheng, Shandong
Luoyang Central Hospital Affiliated to Zhengzhou University
Luoyang, Henan
Maanshan People's Hospital
Ma’anshan, Anhui
Nanyang Central Hospital
Nanyang, Henan
Suzhou Municipal Hospital of Anhui Province
Suzhou, Anhui
Northern Jiangsu People's Hospita!
Yangzhou, Jiangsu
First People's Hospital of Zhengzhou City
Zhengzhou, Henan
Xihua County People's Hospital
Zhoukou, Henan
About this study
The objective of this study is to evaluate the effectiveness and safety of endovascular therapy combined with 25% human albumin in the treatment of acute large vessel occlusive stroke.
Read the detailed description
Stroke is the second leading cause of death worldwide, 85% of which are acute ischemic strokes (AIS). Neuronal death is the primary pathological manifestation of acute ischemic stroke (AIS). Preclinical studies have revealed that neuroprotective agents can reduce neuronal damage and improve neurological outcomes in experimental animals. However, over the past 40 years, clinical translation of neuroprotective drugs has consistently failed. In 2015, with the publication of five randomized controlled trials (RCTs) on thrombectomy for anterior circulation, there was sufficient evidence-based support for thrombectomy in large vessel occlusion of the anterior circulation, ushering us into a new era of AIS treatment - the era of efficient reperfusion therapy. In this context, neuroprotective therapy should be re-examined as an adjunctive approach to reperfusion therapy.
Albumin, the predominant plasma protein synthesized primarily in the liver, possesses various biochemical properties that are expected to confer a neuroprotective effect following acute ischemic stroke.
This study is a multi-center, randomized, double-blind, placebo-controlled clinical study, focusing on patients with acute large vessel occlusive stroke. It aims to investigate the effectiveness and safety of albumin as an adjunctive treatment to endovascular therapy compared with placebo in reducing infarct volume, improving long-term functional outcomes, and daily living activities of patients with acute ischemic stroke in the era of reperfusion therapy.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Intravenous infusion of human albumin, Saline
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous infusion of human albuminDrug
Administer 0.5g/kg of 25% human albumin intravenously as soon as possible within 60 minutes after randomization. And administer 0.5g/kg of 25% ALB intravenously every day on the second, third, and fourth days after randomization.
SalineDrug
Equivalent volume of isotonic saline control
| Study group | Role | What they receive |
|---|---|---|
| Human albumin treatment group | Experimental | Not described Receives: Drug: Intravenous infusion of human albumin |
| Placebo group | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in infarction volume from Day 5 to baseline.
Measured: From 5 days after surgery to baseline
Secondary outcomes (19)
Early neurological improvement within 24 hours
Decrease in National Institute of Health stroke scale (NIHSS) score of ≥8 or NIHSS score of 0-2 within 24 hours. NIHSS scores range from 0 to 42, with higher scores indicating greater neurologic deficit
Measured: within 24 hours
NIHSS score at 24 hours
National Institutes of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating greater neurologic deficit
Measured: at 24 hours
Proportion of successful reperfusion (mTICI 2b/3)
mTICI denotes modified Treatment in Cerebral Ischemia classification, with scores ranging from 0 (no flow) to 3 (normal flow)
Measured: immediate postoperative
NIHSS score at 5 days
National Institutes of Health Stroke Scale (NIHSS)
Measured: at 5 days
Proportion of patients with functional independence (mRS 0-1) at 90 days
Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability
Measured: at 90 days
Proportion of patients with functional independence (mRS 0-2) at 90 days
Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability
Measured: at 90 days
Proportion of patients with Barthel Index of 95-100 at 90 days
Measured: at 90 days
European quality of Life-5 Dimensions (EQ-5D) at 90 days
EQ-5D is a standardized instrument for the measurement of health status. Scores range from -0.33 to 1.00, with higher scores indicating a better quality of life
Measured: at 90 days
Incidence of Symptomatic intracerebral hemorrhage (ICH) Within 24 Hours
Measured: within 24 hours
Incidence of Intracerebral hemorrhage within 24 Hours
Measured: within 24 hours
Neurological deterioration within 24 hours
NIHSS score increased by ≥4 points within 24 hours.
Measured: within 24 hours
Incidence of New-onset atrial fibrillation within 5 days
Measured: within 5 days
Incidence of Pulmonary edema or congestive heart failure within 5 days
Measured: within 5 days
Incidence of Intracerebral hemorrhage within 5 days
Measured: within 5 days
Incidence of Symptomatic intracerebral hemorrhage (ICH) Within 5 days
Measured: within 5 days
Incidence of Decompressive craniectomy within 7 days
Measured: within 7 days
Death within 90 days
Measured: within 90 days
Number of participants who experience adverse events (AEs)
Measured: within 90 days
Number of participants who experience serious adverse events (SAEs)
Measured: within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start10 Aug 2024
- Primary completion20 Dec 2024
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538844
- Sponsor's protocol ID
- ARISE
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Y, Dong X, Zhang W, Hou C, Li C, Chu X, Ma Z, Yi T, Wen C, Liu Y, Sun J, Xu J, Li W, Yang L, Zhang X, Li C, Chen W, Li M, Zhou C, Xu Y, Wu D, Ji X, Wu C. Efficacy and safety of albumin combined with endovascular therapy in the treatment of patients with acute ischemic stroke: a randomized clinical trial. Nat Commun. 2026 Apr 20;17(1):5432. doi: 10.1038/s41467-026-72270-6.
PubMed 42010254Liu Y, Dong X, Chu X, Ma Z, Yi T, Wen C, Liu Y, Sun J, Xu J, Li W, Yang L, Wang B, Shi L, Li J, Zhang X, Li C, Chen W, Li C, Wu D, Hou C, Zhou C, Li M, Xu Y, Wu C, Ji X. Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial. Front Neurol. 2025 Jul 18;16:1570184. doi: 10.3389/fneur.2025.1570184. eCollection 2025.
PubMed 40757028
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Reperfusion Therapy
- ClinicalTrials.gov ID
- NCT06538844
- Acronym / sponsor ID
- ARISE
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effectiveness and safety of endovascular therapy combined with 25% human albumin in the treatment of acute large vessel occlusive stroke.
Detailed description
Stroke is the second leading cause of death worldwide, 85% of which are acute ischemic strokes (AIS). Neuronal death is the primary pathological manifestation of acute ischemic stroke (AIS). Preclinical studies have revealed that neuroprotective agents can reduce neuronal damage and improve neurological outcomes in experimental animals. However, over the past 40 years, clinical translation of neuroprotective drugs has consistently failed. In 2015, with the publication of five randomized controlled trials (RCTs) on thrombectomy for anterior circulation, there was sufficient evidence-based support for thrombectomy in large vessel occlusion of the anterior circulation, ushering us into a new era of AIS treatment - the era of efficient reperfusion therapy. In this context, neuroprotective therapy should be re-examined as an adjunctive approach to reperfusion therapy.
Albumin, the predominant plasma protein synthesized primarily in the liver, possesses various biochemical properties that are expected to confer a neuroprotective effect following acute ischemic stroke.
This study is a multi-center, randomized, double-blind, placebo-controlled clinical study, focusing on patients with acute large vessel occlusive stroke. It aims to investigate the effectiveness and safety of albumin as an adjunctive treatment to endovascular therapy compared with placebo in reducing infarct volume, improving long-term functional outcomes, and daily living activities of patients with acute ischemic stroke in the era of reperfusion therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human albumin treatment group | Experimental | Drug: Intravenous infusion of human albumin |
| Placebo group | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 80 years;
- 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;
- Modified Rankin Scale (mRS) score ≤1 before onset of the disease;
- Alberta Stroke Program Early CT Score (ASPECTS) ≥3 points;
Key exclusion criteria (21 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous infusion of human albuminAdminister 0.5g/kg of 25% human albumin intravenously as soon as possible within 60 minutes after randomization. And administer 0.5g/kg of 25% ALB intravenously every day on the second, third, and fourth days after randomization. | Drug | Human albumin treatment group |
| SalineEquivalent volume of isotonic saline control | Drug | Placebo group |
Primary outcome
Changes in infarction volume from Day 5 to baseline.
Time frame: From 5 days after surgery to baseline
19 secondary outcomes
Early neurological improvement within 24 hours
Time frame: within 24 hours
NIHSS score at 24 hours
Time frame: at 24 hours
Proportion of successful reperfusion (mTICI 2b/3)
Time frame: immediate postoperative
NIHSS score at 5 days
Time frame: at 5 days
Proportion of patients with functional independence (mRS 0-1) at 90 days
Time frame: at 90 days
Proportion of patients with functional independence (mRS 0-2) at 90 days
Time frame: at 90 days
Proportion of patients with Barthel Index of 95-100 at 90 days
Time frame: at 90 days
European quality of Life-5 Dimensions (EQ-5D) at 90 days
Time frame: at 90 days
Incidence of Symptomatic intracerebral hemorrhage (ICH) Within 24 Hours
Time frame: within 24 hours
Incidence of Intracerebral hemorrhage within 24 Hours
Time frame: within 24 hours
Neurological deterioration within 24 hours
Time frame: within 24 hours
Incidence of New-onset atrial fibrillation within 5 days
Time frame: within 5 days
Incidence of Pulmonary edema or congestive heart failure within 5 days
Time frame: within 5 days
Incidence of Intracerebral hemorrhage within 5 days
Time frame: within 5 days
Incidence of Symptomatic intracerebral hemorrhage (ICH) Within 5 days
Time frame: within 5 days
Incidence of Decompressive craniectomy within 7 days
Time frame: within 7 days
Death within 90 days
Time frame: within 90 days
Number of participants who experience adverse events (AEs)
Time frame: within 90 days
Number of participants who experience serious adverse events (SAEs)
Time frame: within 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 42010254Liu Y, Dong X, Zhang W, Hou C, Li C, Chu X, Ma Z, Yi T, Wen C, Liu Y, Sun J, Xu J, Li W, Yang L, Zhang X, Li C, Chen W, Li M, Zhou C, Xu Y, Wu D, Ji X, Wu C. Efficacy and safety of albumin combined with endovascular therapy in the treatment of patients with acute ischemic stroke: a randomized clinical trial. Nat Commun. 2026 Apr 20;17(1):5432. doi: 10.1038/s41467-026-72270-6.
- Derived from this study: PubMed 40757028Liu Y, Dong X, Chu X, Ma Z, Yi T, Wen C, Liu Y, Sun J, Xu J, Li W, Yang L, Wang B, Shi L, Li J, Zhang X, Li C, Chen W, Li C, Wu D, Hou C, Zhou C, Li M, Xu Y, Wu C, Ji X. Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial. Front Neurol. 2025 Jul 18;16:1570184. doi: 10.3389/fneur.2025.1570184. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous infusion of human albumin and Saline in people with Acute Ischemic Stroke, run by Capital Medical University at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in infarction volume from Day 5 to baseline. (time frame: From 5 days after surgery to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06538844, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.