Computed tomography perfusion-based thrombolysis in wake-up stroke

Wake-up stroke (WUS) patients are typically excluded from reperfusion treatment, as the time of symptoms onset is unknown. The purpose of this study is to evaluate the clinical outcome and safety of intravenous thrombolysis with rt-PA in patients with WUS eligible for therapy using computed tomography perfusion criteria (CTP), compared to patients treated with rt-PA within 4.5 h of symptoms onset (non-WUS). This is an experimental, open-label trial, controlled against the best therapy currently in use. Primary endpoints were functional independence after 3 months [modified Rankin scale (mRS) ≤ 1] for clinical outcome and symptomatic intracerebral hemorrhage (SICH) for safety. Secondary endpoints were no or only mild disability after 3 months (mRS ≤ 2) for clinical outcome, total intracerebral hemorrhage (TICH) and contrast-induced nephropathy (CIN) for safety. 170 patients were treated, 143 non-WUS patients and 27 patients with WUS. Strokes of cardioembolic origin were most common in WUS patients (p < 0.001). Primary endpoints: mRS ≤ 1 was found in 35.8 % (non-WUS: 36.4% vs. WUS 33.3%; p = 0.62) and SICH was observed in 3.4 % of non-WUS patients and in WUS patients (p = 0.32). Secondary endpoints: mRS ≤ 2 was observed in 66.4 % of patients (non-WUS: 67.1% vs. WUS 62.9%; p = 0.67), TICH in 13.5 % of patients (13.9 % non-WUS vs. 11.1 % WUS; p = 0.69). CIN was documented in 3.7 % of WUS patients. rt-PA treatment carried out in WUS patients selected on the basis of CTP data demonstrate comparable clinical outcome and safety with respect to non-WUS patients. The study supports the hypothesis that a selected group of WUS patients may be suitable for thrombolysis.