Menu
Not yet recruiting NCT05534360

Tenecteplase Treatment in Ischemic Stroke Registry

Observational Stroke, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke, Acute. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The Tenecteplase Treatment in Acute Ischemic Stroke (TETRIS) Registry is multicenter ambispective observational study of patients with acute ischemic stroke who received intravenous thrombolysis with Tenecteplase

Detailed description

Acute ischemic stroke management has considerably evolved over the last 20 years with the development of reperfusion treatments: intravenous thrombolysis (IVT) with alteplase, which is effective for AIS within 4.5 hours from symptoms onset and up to 9 hours in some cases; and mechanical thrombectomy (MT), in AIS with large vessel occlusion (LVO) within 24 hours from symptoms onset, either after IVT (bridging therapy) or alone in case of IVT contra-indication.

Alteplase is a recombinant form of tissue plasminogen activator (rtPA) that, when bound to fibrin, will activate plasminogen and lead to fibrinolysis and clot dissolution. It is administered at a dose of 0.9 mg/kg (maximum 90 mg) with an intravenous bolus (10% of the dose) followed by a one-hour infusion. Tenecteplase is a genetically modified form of alteplase with greater fibrin specificity and a longer half-life, which allows a simpler one bolus administration at a dose of 0.25 mg/kg (maximum 25 mg).

In the Tenecteplase versus Alteplase before Endovascular Therapy for Ischemic Stroke (EXTEND-IA TNK) randomized clinical trial, which compared tenecteplase and alteplase in bridging therapy for AIS with LVO, tenecteplase achieved a better recanalization rate on arteriography before MT and a better functional outcome at 3 months. Following this trial, tenecteplase was added in stroke guidelines as an alternative to alteplase for IVT in bridging therapy. More recently, the Alteplase compared to Tenecteplase (ACT) trial has shown, in patients with LVO and non-LVO AIS, that tenecteplase is non-inferior to alteplase in terms of functional outcome. It is likely that in the near future tenecteplase will be added as an alternative to alteplase for AIS without LVO. However, while some "real-life" studies have been published on tenecteplase use for AIS with LVO, data on the general use of tenecteplase are still scarce.

The Tenecteplase Treatment in Acute Ischemic Stroke (TETRIS) Registry is multicenter ambispective observational study of patients with acute ischemic stroke who received intravenous thrombolysis with Tenecteplase. The main aim of this registry is to provide routine clinical care data on the use of tenecteplase for IVT for both AIS with and without LVO, in order to further characterize the safety and efficacy of tenecteplase for AIS. Additionally, we aim to use this registry which combines clinical and radiological data to explore other aspects related to AIS management in this cohort.

Primary outcome measures

  • Functional outcome [Time frame: Day 90]
Secondary outcome measures (9)
  • Efficacy on functional independence (mRS ≤ 2) [Time frame: Day 90]
  • Mortality rate [Time frame: Day 90]
  • Early neurological outcome [Time frame: Day 1]
  • Incidence of haemorrhagic transformation [Time frame: Day 1]
  • Incidence of symptomatic intracerebral haemorrhage (sICH) [Time frame: Day 1]
  • Pre-thrombectomy recanalization rate [Time frame: Day 1]
  • Final recanalization rate [Time frame: Day 1]
  • Thrombolysis complication rate [Time frame: Day 1]
  • Thrombectomy complication rate [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Age 18 and older
  • Confirmed acute arterial ischemic stroke on brain imaging (CT or MRI) within 270 minutes of symptoms onset or with perfusion CT or MRI criteria for an extended treatment window or wake-up strokes.
  • Intravenous thrombolysis with tenecteplase

Exclusion criteria

  • Contra-indication to intravenous thrombolysis
  • Intravenous thrombolysis with alteplase
  • Venous ischemic stroke

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Service des Urgences Cérébro-Vasculaires, Hôpitaux Universitaires Pitié-Salpêtrière et Sai — Paris

Publications

  • Gerschenfeld G, Lapergue B, Seners P, Piotin M, Chausson N, Scarcia L, Arquizan C, Costalat V, Olindo S, Marnat G, Guillon B, Bourcier R, Yger M, Allard J, Richard S, Gory B, Pico F, Macian Montoro F, Mounayer C, Ben Hassen W, Venditti L, Caroff J, Clarencon F, Consoli A, Turc G, Alamowitch S; ETIS and TETRIS investigators. IV Tenecteplase Before Thrombectomy Compared With Thrombectomy Alone in Pa PMID 41678809
  • Gerschenfeld G, Turc G, Obadia M, Chausson N, Consoli A, Olindo S, Caroff J, Marnat G, Blanc R, Ben Hassen W, Seners P, Guillon B, Wiener E, Bourcier R, Yger M, Cho TH, Checkouri T, Gory B, Smadja D, Sibon I, Richard S, Piotin M, Eker OF, Pico F, Lapergue B, Alamowitch S; for ETIS and TETRIS study groups. Functional Outcome and Hemorrhage Rates After Bridging Therapy With Tenecteplase or Alteplase PMID 38862134

Identifiers

NCT: NCT05534360 · APHP220465

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗