Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis

Phase 3 Completed 1858 enrolled NHS Greater Glasgow and Clyde Oxford University Hospitals NHS Trust · collab University of Edinburgh · collab University of Glasgow · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The principle research question is: in patients with acute ischaemic stroke eligible for intravenous (IV) thrombolysis, is tenecteplase superior in efficacy to alteplase, based on functional outcome as assessed by modified Rankin Scale distribution at day 90?

Timeline

Start: 2016-12-15
Primary completion: 2023-08-31
Completion: 2024-01-10

Outcome

Met primary endpoint

paper Tenecteplase was non-inferior to alteplase for mRS score distribution at 90 days PMID 39424558 ↗

paper p value for non-inferiority<0·0001 PMID 39424558 ↗

Publications

Muir KW, Ford GA, Ford I, Wardlaw JM, McConnachie A, Greenlaw N, Mair G, Sprigg N, Price CI, MacLeod MJ, Dima S, Venter M, Zhang L, O'Brien E, Sanyal R, Reid J, Sztriha LK, Haider S, Whiteley WN, Kennedy J, Perry R, Lakshmanan S, Chakrabarti A, Hassan A, Marigold R, Raghunathan S, Sims D, Bhandari M, Wiggam I, Rashed K, Douglass C; ATTEST-2 Investigators. Tenecteplase versus alteplase for acute stroke within 4.5 h of onset (ATTEST-2): a randomised, parallel group, open-label trial. Lancet Neurol. 2024 Nov;23(11):1087-1096. doi: 10.1016/S1474-4422(24)00377-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Alteplase	Protein / enzyme biologic	0.9 mg/kg	Intravenous
Subject	Tenecteplase	Protein / enzyme biologic	0.25 mg/kg	Intravenous