Methods:

The RESCUE BT2 investigators enrolled patients with ischemic stroke without occlusion of large or medium-sized vessels and with a National Institutes of Health Stroke Scale score of ≥5 and ≥1 moderately to severely weak limb in a multicenter trial in China. Eligible patients had any of four clinical presentations: ineligible for thrombolysis or thrombectomy and within 24 hours after the patient was last known to be well; progression of stroke symptoms 24-96 hours after onset; early neurologic deterioration after thrombolysis; or thrombolysis with no improvement at 4-24 hours. Patients were assigned to receive intravenous (IV) tirofiban (plus oral placebo) or oral aspirin (100 mg per day, plus IV placebo) for 2 days; all patients then received oral aspirin until day 90. The primary efficacy endpoint was an excellent outcome, defined as a score of 0 or 1 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. Secondary endpoints included functional independence at 90 days and a quality-of-life score. The primary safety endpoints were death and symptomatic intracranial hemorrhage. A modified Poisson regression model was used to estimate the risk ratio and 95% confidence interval (CI) associated with treatment effect for the primary endpoint and other dichotomous endpoints, with adjustment for prespecified covariates.