Table 2.

Observational studies and nonrandomized trials

Study	Haley et al. [16]	Kate et al. [22]	TEMPO-1 [21]	Parsons et al. [17]
Design	Dose-finding	Single arm	Dose escalation	Prospective
Inclusion criteria	NINDS, 1995	CBV or ASPECTS > 6  +  mismatch score > 2	TIA or minor stroke  +  CTA occlusion	Penumbra ≥ 20% core  +  CTA occlusion
n	88	16	50	50
TNK dose (mg/kg) (n)	0.1 (n = 25) 0.2 (n = 25) 0.4 (n = 25) 0.5 (n = 13)	0.25 (n = 16)	0.1 (n = 25) 0.25 (n = 25)	0.1 (n = 15)
Treatment window	3 h	4.5–24 h	12 h	3–6 h for TNK group  < 3 h for alteplase group
Imaging selection	NCCT	CTP or PWI	CT and CTA	Perfusion/angiographic imaging with CT/MRI
Primary outcome	sICH	sICH	Drug-related serious adverse events	Rates of reperfusion 74% TNK vs. 44% Alteplase; P = 0.01 Major vessel recanalization: 10/15 patients TNK vs. 7/29 Alteplase; P = 0.01
sICH	0.1–0.4 mg/kg dose: 0% 0.5 mg/kg dose: 15%	1 (6.3%)	0% in both groups	0% TNK 11.4% Alteplase
Conclusion	TNK 0.1–0.4 mg/kg dose is safe in AIS	TNK is feasible in AIS patients with penumbra 4–24 h after stroke onset	TNK is feasible and safe for TIA or minor stroke with LVO	TNK may be efficacious in AIS within 3–6 h onset with advanced imaging selection