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Tenecteplase Treatment in Ischemic Stroke Registry

Tenecteplase Treatment in Ischemic Stroke Registry

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05534360
Acronym
TETRIS
Enrollment
5000
Registered
2022-09-09
Start date
2022-09-30
Completion date
2028-03-31
Last updated
2022-09-09

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

Conditions

Stroke, Acute

Keywords

Stroke, Ischemic stroke, Thrombolytic therapy, Tenecteplase, Thrombectomy, Cerebrovascular Disorders, Brain diseases, Central Nervous Diseases, Nervous system Diseases, Vascular Diseases, Cardiovascular Diseases

Brief summary

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional outcomeDay 90Modified Rankin score (mRS), score ranging from 0 (no symptom) to 6 (death).

Secondary

MeasureTime frameDescription
Mortality rateDay 90Rate of all-cause mortality
Early neurological outcomeDay 1National Institutes of Health Stroke Scale (NIHSS) score after 24 hours, ranging from 0 (no symptom) to 42 (death)
Incidence of haemorrhagic transformationDay 1Incidence of intracerebral haemorrhage on MRI or CT after 24 hours (±12 hours) according to the ECASS II classification.
Incidence of symptomatic intracerebral haemorrhage (sICH)Day 1Incidence of sICH according to the SITS-MOST definition.
Efficacy on functional independence (mRS ≤ 2)Day 90Rate of functional independence defined as a modified Rankin score 0-2
Final recanalization rateDay 1Rate of complete or near complete recanalization after
Thrombolysis complication rateDay 1Rate of complications linked to intravenous thrombolysis with tenecteplase
Thrombectomy complication rateDay 1Rate of patients with secondary decompressive craniectomy
Pre-thrombectomy recanalization rateDay 1Rate of complete or near complete recanalization, defined as an extended Thrombolysis in Cerebral Infarction (mTICI) 2b50/2b66/2c/3 before thrombectomy

Countries

France

Contacts

Primary ContactSonia Alamowitch, MD
sonia.alamowitch@aphp.fr1 71 97 06 51
Backup ContactGaspard Gerschenfeld, MD, PhD
gaspard.gerschenfeld@aphp.fr1 42 16 24 75

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026