Table 3.
Prospective trials of thrombolysis in WUS and non-WUS SUSO patients.
| Study | Phase | N | SxD (h) | Design | Study drug | Imaging selection | sICH definition | sICH (%) | Primary outcome |
|---|---|---|---|---|---|---|---|---|---|
| AbESTT-IIa | 3 | 808 | 3 | Two arms | Abciximab, placebo | CT (<50% MCA) | NINDS | 5.5 | 90-day mRS adjusted for stroke severity: 32% vs. 33%. |
| Wake-up Strokee | 2 | 40 | 3 | Open label | IV tPA | CT (<1/3 MCA) | ECASS III | 0 | sICH; 52.6% 90-day mRS < 2 |
| Aoki (118) | NA | 10 | 3 | Open label, Single arm | IV tPA | MRI (DWI/FLAIR signal intensity ratio) | ECASS III | 0 | 90-day favorable outcome (mRS ≤ 2) found in four patients. |
| SAIL-ONe | 2 | 20 | 4.5 | Open label | IV tPA | CT or MRI (<1/3 MCA) | ECASS II NINDS | 0 | sICH |
| RESTOREd | 2 | 83 | 6 | Open label, Single arm | IV tPA/IV + IA UK or IA UK | MRI (DWI/PWI/FLAIR) | ECASS II, NINDS | 3.6 | 90-day mRS 0–2: 44.6%. |
| MR WITNESS | 2 | 80 | 4.5 | Open label | IV tPA | MRI (DWI/FLAIR signal intensity ratio) | ECASS III | 1.25 | sICH |
| WAKE-UPc,e | 3 | 800 | 4.5 | Two arms | IV, placebo | MRI (DWI/FLAIR mismatch) | ECASS II, SITS-MOST, NINDS | NA | 90-day mRS 0–1 |
| THAWS | 3 | 300 | 4.5 | Two arms | IV, placebo | MRI (DWI/FLAIR mismatch) | ECASS II, SITS-MOST, NINDS | NA | 90-day mRS 0–1 in Japanese stroke patients. |
| DAWNb | 2/3 | 206 | 6–24 h | Two arms | EVT | CT or MRI (<1/3 MCA, ICA/M1 occlusion, clinical/NIHSS mismatch) | ECASS III | 6 | 90-day mRS 0–2: 48.6% vs. 13.1%. |
| DEFUSE 3b | 3 | 182 | 6–16 h | Two arms | EVT | ICA/M1 occlusion, target mismatch | ECASS II | 7 | 90-day mRS 0–2: 45% vs. 17%. |
aTerminated (808 enrolled).
bHalted for overwhelming efficacy.
cHalted for funding stoppage.
dTreatment group compared with registry of controls.
eTrial enrolled on wake-up stroke patients.
CT, computed tomography; DWI, diffusion-weighted imaging; EVT, endovascular thrombectomy; FLAIR, fluid attenuated inversion recovery; IA, intra-arterial; ICH, intracranial hemorrhage; IV, intravenous; MCA, middle cerebral artery; MRI, magnetic resonance imaging; mRS, modified Rankin scale; PH, parenchymal hematoma; PWI, perfusion weighted imaging; sICH, symptomatic intracranial hemorrhage.