Initiation of oral dual antiplatelet therapy (DAPT) within six hours of the onset of a moderate ischemic stroke improved the likelihood of excellent functional outcomes at 90 days among patients being treated with intravenous thrombolysis, according to results from the TAPIS study published May 8 in The Lancet.

At 60 centers across China, researchers randomized 1,382 patients who were being treated with intravenous thrombolysis to either ticagrelor plus aspirin (DAPT group) or placebo to start within six hours of stroke onset. Ticagrelor or placebo was continued for days two to seven in each group, and open-label aspirin was administered for days two to 90. Patients had a National Institutes of Health Stroke Scale score of 4-10, their median age was 66 years and most (72%) were men.

The primary endpoint was excellent functional outcome (modified Rankin Scale score 0-1) at 90 days, and the primary safety outcome was symptomatic intracranial hemorrhage within 36 hours.

At the 90-day follow-up, 474 (69%) patients in the early DAPT group and 429 (62%) patients in the placebo group met the primary endpoint (risk ratio, 1.11 [95% CI, 1.03-1.20; p=0·008). Additionally, the primary safety outcome occurred in six (0.9%) patients in the DAPT group vs. five (0.7%) patients in the placebo group (risk ratio, 1.20 [95% CI, 0.37-3.93; p=0.76).

"These findings suggest the potentially increased efficacy of early DAPT on the overall subjective quality of life..." write Anxin Wang, PhD, et al. "Further studies specifically powered to assess treatment effects in key subpopulations are warranted to confirm the consistency of early DAPT benefits."

In an accompanying editorial, Bijoy K. Menon, MBBS, MD, writes that the key question remaining after the TAPIS trial is "in which patients the balance of thrombosis and [hemorrhage] becomes [favorable]." Menon emphasizes that TAPIS is a "key piece of evidence about a specific stroke biology."