Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke on Treatment With Direct Oral Anticoagulants: DO-IT - The DOAC Intravenous Thrombolysis Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 906
- 试验地点
- 111
- 主要终点
- Modified Rankin Scale (mRS)
研究概览
简要总结
DO-IT is an international, multicenter, prospective, two-arm, randomized, open label, blinded endpoint superiority trial determining the safety and efficacy of intravenous thrombolysis (IVT) in participants experiencing an acute ischemic stroke (AIS) with recent (within the last 48 hours) intake of direct oral anticoagulant (DOAC). For this purpose, 906 adult participants experiencing an AIS with recent DOAC intake will be enrolled at several high-volume international stroke centers and randomly assigned in a ratio of 1:1 to one of two treatment arms: (1) IVT and standard of care/best medical treatment or (2) standard of care/best medical treatment. The DO-IT trial is a definitive test of the hypothesis that IVT is superior to standard of care for achieving better outcome at 90 days in AIS participants with recent DOAC intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Informed consent (deferred consent when possible according to national legislation)
- •AIS eligible to receive intravenous alteplase/tenecteplase as per standard of care disabling according to the judgement of the treating physician
- •DOAC ingestion within 48 hours prior to enrollment, or patient with an ongoing prescription of DOAC but exact time point of last intake is unknown.
- •Can be randomized within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time OR
- •MRI showing a pattern of "DWI-FLAIR-mismatch", i.e. acute ischemic lesion visibly on DWI ("positive DWI") but no marked parenchymal hyperintensity visible on FLAIR ("negative FLAIR") indicative of an acute ischemic lesion ≤4.5 hours of age AND Treatment can be started within 4.5 hours of symptom recognition (e.g., awakening).
排除标准
- •Contra-indications to IVT by the current standard of care of the treating physicians with the exception of recent DOAC intake as specified above.
- •Intended reversal by specific or unspecific reversal agents
- •Pregnancy or lactating women. To be reasonable sure to exclude women with ongoing pregnancy, women are not considered of childbearing potential if they fulfill the following criteria
- •Age > 55 years OR
- •Age < 55 years and at least 12 months since last menstrual period OR
- •Have had a documented surgical sterilization
- •Patient < 18 years of age (since the benefit of IVT is unproven in this population)
- •Since the benefit of IVT might be smaller in patients in which additional endovascular treatment is planned, the investigators will cap patients with intended mechanical thrombectomy at 20% of the trial population. If this number is reached, the following additional exclusion criterion will be applied:
- •Intended treatment with endovascular reperfusion strategies
研究组 & 干预措施
Intravenous Thrombolysis + Best medical treatment (standard of care)
Patients will receive intravenous administration of Tenecteplase or Alteplase.
干预措施: Tenecteplase or Alteplase (Drug)
结局指标
主要结局
Modified Rankin Scale (mRS)
时间窗: 90 days +/- 2 weeks after randomization
Modified Rankin Scale is a scale that runs from 0-6, running from perfect health without symptoms (0) to death (6).
次要结局
- Dichotomized modified Rankin Scale (mRS) 0-2 (good functional outcome)(90 days +/- 2 weeks post-randomization)
- Change from baseline in stroke severity (National Institutes of Health Stroke Scale, NIHSS)(24 +/- 12 hours after Intervention)
- Health-related Quality of Life (EuroQol 5D-3L questionnaire)(90 days +/- 2 weeks post-randomization)