TETRIS: Tenecteplase Treatment in Ischemic Stroke Registry

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05534360

Collaborator

(none)

5,000

Enrollment

Location

Anticipated Duration (Months)

75.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Tenecteplase Treatment in Ischemic Stroke Registry

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2028

Anticipated Study Completion Date :

Mar 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Tenecteplase All consecutive patients with an arterial acute ischemic stroke treated with intravenous thrombolysis with tenecteplase.

Outcome Measures

Primary Outcome Measures

Functional outcome [Day 90]
Modified Rankin score (mRS), score ranging from 0 (no symptom) to 6 (death).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service des Urgences Cérébro-Vasculaires, Hôpitaux Universitaires Pitié-Salpêtrière et Saint-Antoine	Paris		France

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Sonia Alamowitch, MD, Assistance Publique - Hôpitaux de Paris
Principal Investigator: Gaspard Gerschenfeld, MD, PhD, Assistance Publique - Hôpitaux de Paris