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NCT Number: NCT05534360

Tenecteplase Treatment in Ischemic Stroke Registry

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Functional outcome

    Time frame: Day 90

    Modified Rankin score (mRS), score ranging from 0 (no symptom) to 6 (death).

Secondary outcomes

  1. Efficacy on functional independence (mRS ≤ 2)

    Time frame: Day 90

    Rate of functional independence defined as a modified Rankin score 0-2

  2. Mortality rate

    Time frame: Day 90

    Rate of all-cause mortality

  3. Early neurological outcome

    Time frame: Day 1

    National Institutes of Health Stroke Scale (NIHSS) score after 24 hours, ranging from 0 (no symptom) to 42 (death)

  4. Incidence of haemorrhagic transformation

    Time frame: Day 1

    Incidence of intracerebral haemorrhage on MRI or CT after 24 hours (±12 hours) according to the ECASS II classification.

  5. Incidence of symptomatic intracerebral haemorrhage (sICH)

    Time frame: Day 1

    Incidence of sICH according to the SITS-MOST definition.

  6. Pre-thrombectomy recanalization rate

    Time frame: Day 1

    Rate of complete or near complete recanalization, defined as an extended Thrombolysis in Cerebral Infarction (mTICI) 2b50/2b66/2c/3 before thrombectomy

  7. Final recanalization rate

    Time frame: Day 1

    Rate of complete or near complete recanalization after

  8. Thrombolysis complication rate

    Time frame: Day 1

    Rate of complications linked to intravenous thrombolysis with tenecteplase

  9. Thrombectomy complication rate

    Time frame: Day 1

    Rate of patients with secondary decompressive craniectomy

Study contacts

Contact information is provided by the study sponsor or research team.

Gaspard Gerschenfeld, MD, PhD

CONTACT

[email protected]

1 42 16 24 75 ext. +33

Sonia Alamowitch, MD

CONTACT

[email protected]

1 71 97 06 51 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: TETRIS

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Sep 9, 2022
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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