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Safety and Efficacy of Omega-3 Polyunsaturated Fatty Acids Combined with Recanalization Therapy in Acute Large Vessel Occlusion Stroke (ALIVE): A Multicenter, Double-Blind, Randomized Controlled Trial

Safety and Efficacy of Omega-3 Polyunsaturated Fatty Acids Combined with Recanalization Therapy in Acute Large Vessel Occlusion Stroke (ALIVE): A Multicenter, Double-Blind, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114317
Enrollment
Unknown
Registered
2025-12-10
Start date
2026-01-10
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke

Interventions

Omega-3 group:Nasal feeding/oral administration, 7 capsules twice a day from day 1-7, 4 capsules twice a day from day 8-14, 3 capsules once a day from day 15-90.
Corn oil group:Nasal feeding/oral administration corn oil, 7 capsules twice a day from day 1-7, 4 capsules twice a day from day 8-14, 3 capsules once a day from day 15-90.

Sponsors

Guangdong Medical University Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18-80 years old; 2. The time from onset to randomization is within 12 hours; 3. Based on clinical symptoms or imaging examinations, it is preliminarily judged as anterior circulation large vessel occlusion stroke. CTA/MRA/DSA confirms occlusion of the intracranial segment of the internal carotid artery and the M1 and M2 segments of the middle cerebral artery; 4. NIHSS score >= 6 points; 5. Alberta Stroke Early Diagnosis Program (ASPECTS) score 2-6 points; 6. The patient underwent endovascular treatment; 7. The patient or family member signs a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Confirmed intracranial hemorrhage through computed tomography (CT) or magnetic resonance imaging (MRI) of the skull; 2. MRS score >= 2 points before onset; 3. Pregnant or lactating women; 4. Omega-3 PUFAs allergy; 5. Currently participating in other clinical trials; 6. Systolic blood pressure>185mmHg or diastolic blood pressure>110mmHg, and oral antihypertensive drugs cannot control it; 7. Genetic or acquired bleeding constitution, lack of anticoagulant factors; Or have taken oral anticoagulants with INR>1.7; 8. Blood glucose22.2mol/L (400mg/dl), platelet count220 µ mol/L (2.5mg/dl)); Late stage of any disease leading to an expected life expectancy of less than 6 months; Intracranial aneurysm (diameter greater than 3mm), arteriovenous malformation; Brain tumors with space occupying effects in imaging; Systemic infectious diseases; Expected inability to complete follow-up

Design outcomes

Primary

MeasureTime frame
National Institute of Health stroke scale,NIHSS;

Secondary

MeasureTime frame
Modified Rankin Scale, mRS;Modified Rankin Scale, mRS;A reduction of 4 points or more on NIHSS;An increase of 4 points or more on the NIHSS;EQ-5D ;Conversion of intracranial hemorrhage within 24 hours;

Countries

China

Contacts

Public ContactWangtao Zhong

Guangdong Medical University Affiliated Hospital

barbara3367723@126.com+86 759 236 9970

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026