NCT06301776招募中不适用
A Prospective, Experimental, Multicenter, Open-label, Randomized, Controlled Trial of 3-month Dual Antiplatelet Therapy Followed by Ticagrelor Versus 6-month Dual Antiplatelet Therapy Followed by Ticagrelor After Implanting Bridge
The Fourth Affiliated Hospital of China Medical University1 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2023年12月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months.
研究概览
简要总结
To compare the incidence of the composite endpoints of non-fatal ischaemic stroke, transient ischaemia (TIA) and all-cause mortality at 12-month follow-up after implantation of Bridge for the treatment of symptomatic vertebral artery stenosis in subjects who had been taking different durations of dual-antiplatelet therapy (3 vs 6 months) and ticagrelor monotherapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are suitable for Bridge implantation
- •Symptomatic vertebral artery stenosis with a history of posterior circulation-related ischaemic stroke or TIA despite the use of at least one antithrombotic medications and intervention for risk factors
- •Responsible vertebral artery stenosis (≥70% stenosis, measured by the NASCET method ) confirmed by DSA imaging
- •The patient and/or his/her authorised person understands the purpose of the study, agrees to participate in the study and signs the informed consent form
排除标准
- •Presence of tandem stenotic lesions in the target lesion areaor combined basilar artery stenosis Presence of ≥2 stenotic cerebrovascular lesions requiring concurrent intervention The presence of severe tortuosity or calcification of the target vessel, or the presence of extensive abnormal vascular structural variants that are difficult for catheters or stents to pass or cannot be implanted
- •Lesions or stenosis that is too large and beyond the specification of the stent
- •Non-atherosclerotic stenosis such as atrial fibrillation, vasculitis stenosis, arterial entrapment, smoky disease, active phase of arteritis, or unknown cause
- •Contraindication to heparin, aspirin, tegretol, clopidogrel, or other antiplatelet drugs, and those who cannot tolerate anticoagulant and antiplatelet drug therapy
- •Have had intracranial haemorrhage within 3 months
- •Had a myocardial infarction or large cerebral infarction within 2 weeks
- •Accompanied by other intracranial disease such as aneurysm, arteriovenous malformation, intracranial tumour, intracranial infection, etc
- •Presence of active bleeding or extremely dangerous risk of haemorrhage (e.g. active peptic ulcer disease, gastrointestinal lesions with bleeding risk, malignant tumours with bleeding risk, etc.)
- •Severe cardiac, hepatic, splenic, pulmonary, or renal impairment, or allergy or intolerance to contrast media, rapamycin (Rapamycin) and its derivatives, cobalt-based alloys, or polylactic acid
研究组 & 干预措施
Experimental group
Experimental
3 Months DAPT+9 months ticagrelor monotherapy after Bridge(MicroPort NeuroTech, Shanghai, China) implantation
干预措施: Ticagrelor (Drug)
Control group
Active Comparator
6 Months DAPT+6 months ticagrelor monotherapy after Bridge(MicroPort NeuroTech, Shanghai, China) implantation
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months.
时间窗: 365±60 days
次要结局
- Incidence of all-cause mortality at 12 month.(365±60 days)
- Incidence of target vessel-related stroke and neurological death at 1month(30±7 Days)
- Incidence of in-stent-stenosis at 12 month (subgroup of imaging follow-up).(365±60 days)
- Incidence of the composite endpoint of major bleeding and hemorrhagic stroke at 12-months.(365±60 Days)
- Incidence of stroke and neurological death at 12 month.(365±60 Days)
研究者
Lianbo Gao
Chief Physician
The Fourth Affiliated Hospital of China Medical University
研究点 (1)
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