TENACITY – A Phase III, prospective, randomized, open-label, blinded endpoint assessment (PROBE) to assess efficacy and safety of i.v. tenecteplase vs standard of care in patients with acute ischemic stroke (including wake-up stroke), last known well >4.5 h with imaging evidence of salvageable ischemic tissue

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522542-40-00

Enrollment

185

Registered

2026-03-11

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Brief summary

mRS 0-1 at Day 90

Detailed description

mRS (ordinal) at Day 90, Early neurological improvement (reduction in acute – 24-hour NIHSS score of ≥8 or value of 0/1), mRS 0-2 at Day 90, sICH as defined by SITS-MOST criteria at 36 h, sICH as defined by ECASS III criteria at 36 h, Death from any cause within 90 days

Interventions

DRUGMetalyse 5 000 units (25 mg) powder for solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
mRS 0-1 at Day 90	—

Secondary

Measure	Time frame
mRS (ordinal) at Day 90, Early neurological improvement (reduction in acute – 24-hour NIHSS score of ≥8 or value of 0/1), mRS 0-2 at Day 90, sICH as defined by SITS-MOST criteria at 36 h, sICH as defined by ECASS III criteria at 36 h, Death from any cause within 90 days	—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 13, 2026