A Multi-center, Randomized, Open-label Blinded Endpoint (PROBE), Phase III Study, for the Comparation of Tenecteplase (TNK) Versus Alteplase, With a 1:1 Allocation, Before Thrombectomy in Patients With Acute Ischemic Stroke and Large Vessel Occlusion Suspicion in Catalonia (TNK-CAT)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Modified Rankin scale score at 3 months
研究概览
简要总结
Background: The TNKCAT trial represents an innovative approach to optimize timely reperfusion in the Mothership and Drip-and-Ship scenarios. The logistic advantage of a single bolus infusion of TNK (compared to 1-h infusion of tPA) would markedly reduce the needle-to-groin and Door-in- door-out time. The implementation of a quality improvement package (QIP) in the TNKCAT trial would directly improve the quality and efficiency of the Health Care System. In addition, an improvement of transfer models would reduce the cost of unnecessary transfers, together with the fact that TNK is up to 50% less expensive than tPA, makes the TNKCAT in firm line with the sustainability strategy of the National Health Care system.
Outcomes: The aim of the present study is to determine the safety and efficacy of TNK (0.25mh/kg) compared to tPA (0.9 mg/kg) in patients with Large Vessel Occlusion (LVO) suspicion, candidates for thrombectomy, in both Mothership and Drip-and-Ship scenarios.
Study Duration: 2 years. Patients will participate in the trial for 3 months.
Study design: Multicentre, prospective, randomized open-label blinded endpoint (PROBE) phase III study in acute stroke patients with LVO suspicion within 4.5 hours of stroke onset, candidates for EVT. Patients will be randomized 1:1 to standard dose tPA (0.9 mg/kg) or TNK (0.25mg/kg) before EVT.
Clinical, imaging and outcome data will be collected at baseline, 24-36 hours, day 3, day 5 and day 90.
Estimated enrollment: 500 patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical outcome at day 90 will be obtained by centralized telephone call of the mRS in a blinded manner by certified personnel of the Catalan Stroke Program.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible to undergo intravenous thrombolysis (tPA or TNK) within 4.5 hours after the onset of ischemic stroke.
- •Suspicion of Cerebral vascular occlusion on brain imaging.
- •Age >18 years old
- •Men and women (women with child-bearing potential are excluded, unless pregnancy test negative/ confirmed menstrual period/ postmenopausal or hysterectomy).
- •A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- •Informed consent obtained from subject or acceptable subject surrogate (i.e. next of kin, or legal representative), or Differed Inform Consent (DIC) to avoid any delay in the initiation of iv thrombolysis. The DIC will be sign by the patient or next of kin at any time after the tPA or TNK treatment is started.
- •Exclusion criteria:
- •Patients with severe preexisting disability, defined as a modified Rankin scale score >
- •Glasgow Coma Scale score ≤
- •Known hemorrhagic diathesis, coagulation factor deficiency, or antivitamin K oral anticoagulant therapy with INR >3.
- •Subjects on factor Xa inhibitors (e.g. apixaban) or direct thrombin inhibitors are eligible for participation.
- •Severe, sustained and uncontrollable hypertension (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg).
- •Serious, advanced, or terminal illness with anticipated life expectancy of less than 3 months.
- •Patients that are unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas).
- •Patient participating in a randomized study, involving an investigational drug or device that would impact this study.
- •Suspicion of aortic dissection presumed septic embolus, or suspicion of bacterial endocarditis.
- •Imaging exclusion criteria:
- •Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- •Cerebral vasculitis.
- •CT or MRI evidence of hemorrhage
- •Significant mass effect with midline shift.
- •Evidence of intracranial tumor.
- •Subjects with known occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
排除标准
- 未提供
研究组 & 干预措施
Tenecteplase (TNK)
Drug: Alteplase (tPA) Dose: 0.9 mg/kg Route: Intravenous (IV) infusion
干预措施: Tenecteplase (Drug)
Alteplase (tPA)
Drug: Tenecteplase (TNK) Dose: 0.25 mg/kg Route: Intravenous (IV) bolus injection
干预措施: Tenecteplase (Drug)
结局指标
主要结局
Modified Rankin scale score at 3 months
时间窗: 3 months
Shift analysis of the modified Rankin scale score at 3 months
Mortality rate
时间窗: 3 months
Mortality at 3 months
Symptomatic intracerebral haemorrhage (ICH) and neurological deterioration
时间窗: 24 -36hours
Symptomatic ICH defined as intracerebral haemorrhage (PH2) within 36 hours of treatment, combined with neurological deterioration leading to an increase of ≥ 4 points on the National institute of Health Stroke Scale (NIHSS) from baseline, or the lowest NIHSS value between baseline and 24 hours.
次要结局
- Rates of mRS 0-1 at 3 months(3 months)
- First pass TICI 3, final TICI 2b-3(immediately after the procedure)
- Time metrics between TNKCAT and non-TNKCAT centers(at the end of the study)
- Rates of mRS 0-2 at 3 months(3 months)
- Rates of pre-interventional recanalization(during the procedure)
- Distal embolization during EVT(during the procedure)
- Final infarct volume on follow up CT(24-36 hours follow up)
- Dramatic clinical recovery before endovascular treatment (EVT)(before the procedure)
- Needle-to-groin times and DIDO times(immediately after the procedure)