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临床试验/NCT05534360
NCT05534360尚未招募不适用

Tenecteplase Treatment in Ischemic Stroke Registry

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2022年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
5,000
试验地点
1
主要终点
Functional outcome

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Contra-indication to intravenous thrombolysis
  • Intravenous thrombolysis with alteplase
  • Venous ischemic stroke

结局指标

主要结局

Functional outcome

时间窗: Day 90

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

次要结局

  • Mortality rate(Day 90)
  • Efficacy on functional independence (mRS ≤ 2)(Day 90)
  • Early neurological outcome(Day 1)
  • Thrombolysis complication rate(Day 1)
  • Incidence of haemorrhagic transformation(Day 1)
  • Incidence of symptomatic intracerebral haemorrhage (sICH)(Day 1)
  • Pre-thrombectomy recanalization rate(Day 1)
  • Final recanalization rate(Day 1)
  • Thrombectomy complication rate(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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