年轻隐源性卒中患者卵圆孔未闭闭合后停止抗血栓治疗 (HALTI)
年轻隐源性卒中患者卵圆孔未闭闭合后停止抗血栓治疗。 HALTI 试验
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
研究概览
详细说明
Young patients with a cryptogenic ischemic event undergoing transcatheter PFO closure exhibit a low but clinically relevant risk of bleeding (overall and major bleeding) at long-term follow-up, eventually exceeding the risk of ischemic events.
Importantly, the vast majority of major bleeding events seem to occur in patients receiving antiplatelet therapy. Preliminary data suggest that antiplatelet therapy discontinuation is not associated with any increase in ischemic events, and could potentially translate into a lower rate of major bleeding events at longer term follow-up. We therefore hypothesize that in young patients without any other comorbidities increasing the risk of stroke, shorter-term (≤1 year instead of lifelong) antiplatelet treatment could be a safe option following PFO closure.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Melanie Cote, MSc
- 电话号码：14186537270
- 邮箱：melanie.cote@criucpq.ulaval.ca
研究联系人备份
- 姓名：Josep Rodes-Cabau, MD
- 电话号码：4186568711
- 邮箱：josep.rodes@criucpq.ulaval.ca
学习地点
-
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Quebec
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Québec、Quebec、加拿大、G1V 4G5
- 招聘中
- IUCPQ
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接触：
- Melanie Cote, MSc
- 电话号码：Rodes-Cabau 4186568711
- 邮箱：josep.rodes@criucpq.ulaval.ca
-
接触：
- Josep Rodes-Cabau, MD
- 电话号码：4186568711
- 邮箱：josep.rodes@criucpq.ulaval.ca
-
首席研究员：
- Josep Rodes-Cabau, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Successful transcatheter PFO closure with any approved device
- Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure
Exclusion Criteria:
->60 year-old
- RoPE score <6
- Residual shunt ≥moderate following PFO closure
- Atrial fibrillation following PFO closure
- Presence of ≥2 cardiovascular risk factors (smoking, hypertension, dyslipidemia)
- Diabetes mellitus
- Thrombophilia (factor V Leiden, factor II mutation, anticardiolipin antibodies, lupus anticoagulant, anti-b2 glycoprotein-I antibodies, protein C deficiency, protein S deficiency)
- Recurrent cerebrovascular event (stroke, TIA) within the year following PFO closure
- Failure to provide signed informed consent
- Absolute contraindications for an MRI study
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Antiplatelet treatment discontinuation
At 12 months post-PFO closure, patients will discontinue the antiplatelet treatment. All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure. |
All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Presence of new stroke events
大体时间：12 months
|
1)Acute episode of a focal or global neurological deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax or other new neurological symptom(s) consistent with stroke.(2)Duration of a focal or global neurological deficit ≥ 24 hours OR < 24 hours if available neuroimaging documents a new hemorrhage or infarct; OR the neurological deficit results in death. |
12 months
|
|
Presence of new ischemic lesions
大体时间：24-month follow-up
|
Evaluated by MRI |
24-month follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of new cerebral ischemic lesions
大体时间：24-month follow-up
|
Evaluated by MRI |
24-month follow-up
|
|
Volume of new cerebral ischemic lesions
大体时间：24-month follow-up
|
Evaluated by MRI |
24-month follow-up
|
|
Number of ischemic events
大体时间：24-month follow-up
|
Stroke, TIA |
24-month follow-up
|
|
Number of ischemic events
大体时间：3-year follow-up
|
Stroke, TIA |
3-year follow-up
|
|
Number of ischemic events
大体时间：4-year follow-up
|
Stroke, TIA |
4-year follow-up
|
|
Number of ischemic events
大体时间：5-year follow-up
|
Stroke, TIA |
5-year follow-up
|
|
Number of ischemic events
大体时间：6-year follow-up
|
Stroke, TIA |
6-year follow-up
|
|
Number of ischemic events
大体时间：7-year follow-up
|
Stroke, TIA |
7-year follow-up
|
|
Number of ischemic events
大体时间：8-year follow-up
|
Stroke, TIA |
8-year follow-up
|
|
Number of ischemic events
大体时间：9-year follow-up
|
Stroke, TIA |
9-year follow-up
|
|
Number of ischemic events
大体时间：10-year follow-up
|
Stroke, TIA |
10-year follow-up
|
|
Rate of bleeding
大体时间：24-month follow-up
|
Life-threatening, major or minor bleeding |
24-month follow-up
|
|
Rate of bleeding
大体时间：3-year follow-up
|
Life-threatening, major or minor bleeding |
3-year follow-up
|
|
Rate of bleeding
大体时间：4-year follow-up
|
Life-threatening, major or minor bleeding |
4-year follow-up
|
|
Rate of bleeding
大体时间：5-year follow-up
|
Life-threatening, major or minor bleeding |
5-year follow-up
|
|
Rate of bleeding
大体时间：6-year follow-up
|
Life-threatening, major or minor bleeding |
6-year follow-up
|
|
Rate of bleeding
大体时间：7-year follow-up
|
Life-threatening, major or minor bleeding |
7-year follow-up
|
|
Rate of bleeding
大体时间：8-year follow-up
|
Life-threatening, major or minor bleeding |
8-year follow-up
|
|
Rate of bleeding
大体时间：9-year follow-up
|
Life-threatening, major or minor bleeding |
9-year follow-up
|
|
Rate of bleeding
大体时间：10-year follow-up
|
Life-threatening, major or minor bleeding |
10-year follow-up
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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