In stroke patients with multiple acute infarcts, ticagrelor-aspirin improved 90-day functional outcomes versus placebo (64.4% vs 53.4%; RR 1.21, 95% CI 1.02-1.42).
RCT (n=1,307)
double-blind
randomized
Yes
Does early oral ticagrelor-aspirin improve functional outcomes at 90 days in patients with moderate noncardioembolic acute ischemic stroke receiving intravenous thrombolysis?
Early dual antiplatelet therapy with ticagrelor and aspirin may offer targeted functional benefits without excess bleeding in stroke patients with multiple acute infarcts following intravenous thrombolysis.
Relative Risk: 1.21 (95% CI 1.02–1.42)
Absolute Event Rate: 64.4% vs 53.4%
BACKGROUND: Whether diffusion‑weighted imaging infarction patterns influence the efficacy and safety of early oral ticagrelor‑aspirin with intravenous thrombolysis in moderate acute ischemic stroke is uncertain. We assessed treatment effects by infarction pattern in this thrombolysis setting. METHODS: This was a subgroup analysis of the TAPIS trial (Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis in Patients With Ischemic Stroke), a 60-center, randomized, double‑blind trial in China. Patients aged 18 to 80 years with noncardioembolic stroke (National Institutes of Health Stroke Scale score 4–10) who received intravenous thrombolysis within 4.5 hours of onset were randomized within 6 hours to ticagrelor‑aspirin or placebo. Diffusion‑weighted imaging patterns were centrally adjudicated as multiple acute infarcts (MAIs; ≥2 lesions) or non‑MAIs (single infarction or diffusion‑weighted imaging–negative). The primary efficacy outcome was modified Rankin Scale score of 0 to 1 at 90 days; safety outcome was symptomatic intracranial hemorrhage. Treatment‑by‑pattern interaction was assessed. RESULTS: Among 1307 patients (94.6% of full analysis set; median age, 65.5 years; 71.2% male; median National Institutes of Health Stroke Scale score, 6.0), 409 (31.3%) had MAIs and 898 (68.7%) non‑MAIs (20.8% diffusion‑weighted imaging–negative, 79.2% single infarction). MAIs were associated with poorer prognosis than non‑MAIs (excellent outcome: 58.9% versus 69.2%; adjusted risk ratio, 0.92 95% CI, 0.84–1.00). Ticagrelor‑aspirin was associated with a higher likelihood of excellent outcome versus placebo in MAIs (64.4% versus 53.4%; risk ratio, 1.21 95% CI, 1.02–1.42), whereas no significant benefit was observed in non‑MAIs (71.2% versus 67.1%; risk ratio, 1.06 95% CI, 0.97–1.16; P interaction =0.18). Early neurological improvement showed significant heterogeneity by infarction pattern ( P interaction =0.02); the treatment‑by‑pattern interaction for the primary outcome was nominally significant after adjusting for rescue tirofiban use ( P =0.04). Symptomatic intracranial hemorrhage occurred in MAIs: 1 of 205 (0.5%) versus 2 of 204 (1.0%); non‑MAIs: 1 of 448 (0.2%) versus 1 of 450 (0.2%). CONCLUSIONS: In thrombolyzed patients with moderate noncardioembolic stroke, MAIs were associated with poorer functional outcomes. Early ticagrelor‑aspirin showed directionally consistent benefits without excess bleeding in patients with MAIs, though the primary interaction was not significant. These hypothesis‑generating findings may inform future trials of diffusion‑weighted imaging infarction pattern as an imaging biomarker to guide antiplatelet therapy in early reperfusion. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT06316570.
Zi et al. (2026) conducted an RCT in moderate acute ischemic stroke (n=1,307). Ticagrelor-aspirin vs. Placebo was evaluated on modified Rankin Scale score of 0 to 1 at 90 days in patients with multiple acute infarcts (MAIs) (RR 1.21, 95% CI 1.02-1.42). In stroke patients with multiple acute infarcts, ticagrelor-aspirin improved 90-day functional outcomes versus placebo (64.4% vs 53.4%; RR 1.21, 95% CI 1.02-1.42).