Efficacy and Safety of Intravenous Tenecteplase Before Endovascular Thrombectomy for Acute Ischemic Stroke: The Multicenter, Randomized, BRIDGE-TNK Trial Protocol.

Abstract

Six randomized trials have not detected a difference between intravenous alteplase plus endovascular thrombectomy and endovascular thrombectomy alone in stroke. Tenecteplase, a recombinant human tenecteplase tissue-type plasminogen activator, is a genetically modified variant of alteplase. It is unclear whether the outcomes are different if alteplase is replaced with tenecteplase. This trial aims to determine whether intravenous tenecteplase within 4.5 hours of time last known well confers benefit in patients with acute ischemic stroke with large-vessel occlusion who undergo endovascular thrombectomy. BRIDGE-TNK (Thrombectomy With Versus Without rhTNK-tPA in Stroke) is an investigator-initiated, multicenter, prospective, randomized, open-label trial with blinded end point evaluation conducted at 40 thrombectomy-capable centers in China. This trial will randomize 544 patients with intravenous thrombolysis-eligible stroke (272 in each arm) with large-vessel occlusion within 4.5 hours of last known well to receive bridging intravenous tenecteplase with endovascular thrombectomy (tenecteplase-plus-thrombectomy group) or endovascular thrombectomy alone (thrombectomy-alone group). The primary outcome is the proportion of patients achieving functional independence, defined as a score of 0 to 2 on the modified Rankin Scale, at 90 days. Safety will be assessed via symptomatic intracranial hemorrhage at 48 hours and death at 90 days. BRIDGE-TNK will provide important data on the role of intravenous tenecteplase before endovascular thrombectomy in patients with acute ischemic stroke with large-vessel occlusion who can be treated within 4.5 hours of last known well. URL: https://clinicaltrials.gov. Unique identifier: NCT04733742.