EXTEND-IA DNase
(2026)Objective
Phase 2 dose-finding umbrella trial testing whether IV DNase (degrading neutrophil extracellular traps) before EVT improves early reperfusion compared with historical EXTEND-IA TNK control.
Study Summary
• Primary eTICI 2b-3 on initial angiogram without sICH: 15% vs 18% vs 19% vs 21% (NS across doses).
• Versus historical 20% (TNK) or 10% (tPA).
• sICH 1.3% (overall); mortality 13.3% (overall).
• Did not meet pre-specified promise-of-efficacy criteria; safe with dose-dependent reperfusion trend.
• Versus historical 20% (TNK) or 10% (tPA).
• sICH 1.3% (overall); mortality 13.3% (overall).
• Did not meet pre-specified promise-of-efficacy criteria; safe with dose-dependent reperfusion trend.
Intervention
IV DNase bolus before EVT at 0.125, 0.25, 0.5, or 1 mg/kg
Inclusion Criteria
Australia. Onset <=4.5 h; IV thrombolysis + EVT eligible; ICA/M1/M2/basilar occlusion; no core volume limit.
Study Design
Arms: Four DNase doses vs historical EXTEND-IA TNK (IVT + EVT) control
Patients per Arm: Four DNase dose arms (sample size not specified per dose); compared to historical EXTEND-IA TNK control
Outcome
• Primary eTICI 2b-3 on initial angiogram w/o sICH: 15% / 18% / 19% / 21% (NS).
• Historical TNK control: 20%; tPA control: 10%.
• sICH (overall): 1.3%.
• Mortality (overall): 13.3%.
• None of the dose arms provided >95% confidence that observed rate exceeded control.
• Historical TNK control: 20%; tPA control: 10%.
• sICH (overall): 1.3%.
• Mortality (overall): 13.3%.
• None of the dose arms provided >95% confidence that observed rate exceeded control.