Tenecteplase Treatment in Ischemic Stroke Registry

Stroke, Acute Clinical Trial

— TETRIS  

Official title:

Tenecteplase Treatment in Ischemic Stroke Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05534360
• Other study ID #: APHP220465
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: March 2028

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Sonia Alamowitch, MD
• Phone: 1 71 97 06 51
• Email: sonia.alamowitch[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
France	Service des Urgences Cérébro-Vasculaires, Hôpitaux Universitaires Pitié-Salpêtrière et Saint-Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome	Modified Rankin score (mRS), score ranging from 0 (no symptom) to 6 (death).	Day 90
Secondary	Efficacy on functional independence (mRS = 2)	Rate of functional independence defined as a modified Rankin score 0-2	Day 90
Secondary	Mortality rate	Rate of all-cause mortality	Day 90
Secondary	Early neurological outcome	National Institutes of Health Stroke Scale (NIHSS) score after 24 hours, ranging from 0 (no symptom) to 42 (death)	Day 1
Secondary	Incidence of haemorrhagic transformation	Incidence of intracerebral haemorrhage on MRI or CT after 24 hours (±12 hours) according to the ECASS II classification.	Day 1
Secondary	Incidence of symptomatic intracerebral haemorrhage (sICH)	Incidence of sICH according to the SITS-MOST definition.	Day 1
Secondary	Pre-thrombectomy recanalization rate	Rate of complete or near complete recanalization, defined as an extended Thrombolysis in Cerebral Infarction (mTICI) 2b50/2b66/2c/3 before thrombectomy	Day 1
Secondary	Final recanalization rate	Rate of complete or near complete recanalization after	Day 1
Secondary	Thrombolysis complication rate	Rate of complications linked to intravenous thrombolysis with tenecteplase	Day 1
Secondary	Thrombectomy complication rate	Rate of patients with secondary decompressive craniectomy	Day 1

External Links

•   Institutional study link