Clinical trial NCT05534360: Tenecteplase Treatment in Ischemic Stroke Registry
Official title: Tenecteplase Treatment in Ischemic Stroke Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive adult patients with an acute arterial ischemic stroke who received intravenous thrombolysis with tenecteplase in the participating centers.

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.

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

Primary outcomes:
measure: Functional outcome
timeFrame: Day 90
Secondary outcomes:
measure: Efficacy on functional independence (mRS ≤ 2)
timeFrame: Day 90
measure: Mortality rate
timeFrame: Day 90
measure: Early neurological outcome
timeFrame: Day 1
measure: Incidence of haemorrhagic transformation
timeFrame: Day 1
measure: Incidence of symptomatic intracerebral haemorrhage (sICH)
timeFrame: Day 1
measure: Pre-thrombectomy recanalization rate
timeFrame: Day 1
measure: Final recanalization rate
timeFrame: Day 1
measure: Thrombolysis complication rate
timeFrame: Day 1
measure: Thrombectomy complication rate
timeFrame: Day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Service des Urgences Cérébro-Vasculaires, Hôpitaux Universitaires Pitié-Salpêtrière et Saint-Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sonia Alamowitch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Gaspard Gerschenfeld, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: