Effects of Add‐On Icosapent Ethyl With Standard Treatment on Functional Outcomes and Inflammatory Biomarkers in Acute Ischemic Stroke: A Blinded Randomized Controlled Trial

Background

Ischemic stroke, a major cause of mortality and long‐term disability, results from the abrupt cessation of cerebral blood flow due to vascular occlusion or rupture. Icosapent Ethyl (EPA‐EE), approved for hypertriglyceridemia, has anti‐inflammatory and antithrombotic properties that may lessen ischemic damage.

Objectives

This trial evaluates the impact of EPA‐EE on functional recovery and inflammatory markers in patients with acute ischemic stroke.

Methods

In a blinded, randomized controlled trial (RCT), adults (≥ 18 years) with acute ischemic stroke were assigned to receive either 2000 mg/day EPA‐EE (EPA group) or a matched placebo alongside standard treatment for 12 weeks. Functional outcomes were measured using the modified Rankin scale (mRS) and national institutes of health stroke scale (NIHSS), while inflammatory biomarkers, interleukin‐6 (IL‐6) and C‐reactive protein (CRP), were assessed at baseline and at the 7th day.

Results

Of 178 patients screened, 90 were randomized, and 80 completed the 12‐week intervention. The EPA group showed significantly greater functional improvement, with mean mRS score reductions of 2.18 ± 0.61 compared to 1.38 ± 0.66 in the placebo group ( p =  0.001) and NIHSS score reductions of 5.00 ± 1.83 versus 3.38 ± 1.38 ( p =  0.001). IL‐6 levels decreased by 6.32 ± 5.69 pg/mL in the EPA group compared to 2.95 ± 4.11 pg/mL in the placebo group ( p =  0.003). Changes in CRP levels were not statistically significant ( p =  0.142). EPA‐EE at 2000 mg/day was well tolerated, with no serious adverse events reported.

Conclusion

EPA‐EE administration significantly improves functional outcomes and reduces IL‐6 levels in patients with acute ischemic stroke, suggesting its potential as an effective add‐on therapy.

Trial Registration: ClinicalTrials.gov identifier: IRCT20170608034390N15.