Efficacy and safety of minocycline in patients with acute ischaemic stroke (EMPHASIS): a multicentre, double-blind, randomised controlled trial

Summary

At 58 Chinese centers, EMPHASIS randomized 1,724 patients with ischemic stroke within 72 hours and NIHSS 4-25 to a short oral minocycline course or placebo plus usual care. Excellent 90-day functional outcome (mRS 0-1) occurred in 447/850 (52.6%) versus 403/851 (47.4%); adjusted RR 1.11 (95% CI 1.03-1.20; P=.0061). Serious adverse events were 4.6% versus 5.9% (P=.24).

Why it matters

Promising adjunctive evidence for stroke-service discussion, not a reason to start routine ED minocycline or delay reperfusion assessment. A later trial among successfully thrombectomized patients did not improve its separate infarct-growth endpoint.

Main findings

• Primary mRS 0-1: 447/850 (52.6%) versus 403/851 (47.4%); adjusted RR 1.11 (95% CI 1.03-1.20; P=.0061).
• Ordinal mRS shift adjusted common OR 1.19 (95% CI 1.03-1.38).
• Serious adverse events 40/862 (4.6%) versus 51/862 (5.9%); P=.24.
• Later MIST-A phase 2 trial in a distinct successfully thrombectomized group had no infarct-growth benefit.

Limitations

Median NIHSS was 5 and few participants received reperfusion, limiting generalization to severe stroke and post-thrombectomy populations. The later MIST-A study is not a direct replication. Primary abstract only, not full Lancet text, was reviewed.