2024-520414-21-00招募中3 期
“Intravenous Thrombolysis With Tenecteplase Plus Thrombectomy Versus Thrombectomy Alone In Patients With A Large Ischemic Stroke: A Multicentre Randomized Controlled Trial” THE IVT ALL IN TRIAL
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 486
- 试验地点
- 36
- 主要终点
- The primary outcome is the rate of good functional outcome (independent ambulation) at 3 months defined as a modified Rankin scale (mRS) score of 0-3. mRS scores will be determined by certified raters unaware of the treatment arm or baseline characteristics of the individual patient by in person interview or, if not possible, by telephone.
研究概览
简要总结
To assess which treatment strategy between intravenous thrombolysis with tenecteplase plus thrombectomy and thrombectomy alone has a superior efficacy in terms of 3-month functional outcome for LVOS patients with large cores.
研究设计
- 分配方式
- Randomized
- 主要目的
- Ivt All In Trial
- 盲法
- Double (Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- • Age ≥ 18 years
- • mRS ≤ 1 before stroke
- • Anterior circulation LVOS eligible to MT within 24 hours of onset or unknown onset with a DWI-FLAIR mismatch
- • Large core defined either as: - ASPECTS 2-5 or a core volume between 70 and 130 ml on MRI or perfusion CT for patients with process times compatible with IVT administration within 4.5 hours of onset or unknown onset with process times compatible with IVT administration within 4.5 hours of last seen well or unknown onset with a DWI-FLAIR mismatch - ASPECTS 2- 5 with a core volume ≤ 70 ml and core/perfusion mismatch > 1.2 for patients with process times compatible with IVT administration within 4.5 and 9 hours of onset, defined as the mid-point between last known to be normal and symptoms constatation in case of unknown onset
- • Written informed consent signed by the patient or the trustworthy person / family member / close relative, or inclusion in case of emergency. (To note, in the latter case, written informed consent should be signed by the patient (if needed, by trustworthy person, family member or close relative) as soon as possible (article 35 of the European regulation N°536/2014)).
排除标准
- •Anterior circulation stroke with a distal occlusion not eligible to MT
- • Posterior circulation stroke
- • Pregnancy or breastfeeding woman
- • Any contraindication to IVT other than those related to the NIHSS score upper limit, infarct size and symptoms-to-onset time, such as (but not limited to): * Persistent incapacity to lower blood pressure under 185/110 mmHg * Respiratory or hemodynamic failure * Externalized bleeding
- • Any contra-indication to MT: * Contra-indication to femoral, radial or humeral arterial puncture * Allergy to iodinated contrast media
- • Anticipated life expectancy of less than 3 months
- • Participation in another interventional clinical trial evaluating a health product or any randomized clinical trial
- • Absence of affiliation to National French social security system
- • Under legal protection measure (tutorship or curatorship) and patient deprived of freedom
研究组 & 干预措施
Metalyse 5 000 units (25 mg) powder for solution for injection
Test
干预措施: Metalyse 5 000 units (25 mg) powder for solution for injection (Drug)
结局指标
主要结局
The primary outcome is the rate of good functional outcome (independent ambulation) at 3 months defined as a modified Rankin scale (mRS) score of 0-3. mRS scores will be determined by certified raters unaware of the treatment arm or baseline characteristics of the individual patient by in person interview or, if not possible, by telephone.
The primary outcome is the rate of good functional outcome (independent ambulation) at 3 months defined as a modified Rankin scale (mRS) score of 0-3. mRS scores will be determined by certified raters unaware of the treatment arm or baseline characteristics of the individual patient by in person interview or, if not possible, by telephone.
次要结局
- Incremental cost-utility ratio
- Clinical outcomes - early neurological improvement, defined as a ≥ 8-points decrease of the NIHSS score or a NIHSS score ≤ 1 at day 1 - 3-month functional independence (mRS score ≤ 2) - distribution of 3-month mRS scores - one-year independent ambulation (mRS score ≤ 3) - one-year functional independence (mRS score ≤ 2)
- Radiological outcomes - successful, excellent and complete recanalisation rates defined as an extended Treatment In Cerebral Ischemia (eTICI) scores of 2b50/2b67/2c/3, 2c/3 and 3 respectively on the first angiographic run, after the first pass and at the end of the procedure - mean change in infarct volume from baseline at day 1, defined as: (day 1 volume) – (baseline volume
- Safety outcomes - early neurological worsening defined as a ≥ 4-point increase on the NIHSS score within 24 hours due to the stroke itself - intracranial hemorrhage (ICH) according to the Heidelberg Bleeding Classification - symptomatic ICH, scored according to the Heidelberg Bleeding Classification - 3-month and 1-year mortality - adverse events - serious adverse events
研究者
Gaspard GERSCHENFELD
Scientific
Assistance Publique Hopitaux De Paris
研究点 (36)
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