NL-OMON50683已完成不适用
MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus prolonged DAPT regimen - Master DAPT
European Cardiovascular Research Institute (ECRI-9) bv0 个研究点目标入组 550 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria after index PCI
- •After index PCI, patients aged 18 years or more are eligible for inclusion into
- •the study if the following criteria are met.
- •1) At least one among the HBR criteria (as defined below) is met.
- •2) All lesions are successfully treated with Ultimaster stent in the context of
- •routine clinical care, i.e. post-procedural angiographic diameter stenosis <20%
- •by visual estimation
- •3) Free from any flow-limiting angiographic complications (i.e. significant
- •untreated dissection or major side-branch occlusion), which require prolonged
- •DAPT duration based on operator*s opinion.
- •4) All stages of PCI are complete (if any) and no further PCI is planned.
- •Inclusion criteria at one-month randomization visit
- •At randomization visit (one month after index PCI), the following criteria must
- •1) Fulfilment of at least one HBR criterion (as defined below), or on the basis
- •of post-PCI actionable (i.e. requiring medical attention) non-access site
- •related bleeding episode
- •2) Uneventful 30-day clinical course, i.e. free from spontaneous MI,
- •symptomatic restenosis, stent thrombosis, stroke and any revascularization
- •(coronary and non-coronary) requiring prolonged DAPT
- •3) If not on OAC,
- •a. Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor
- •b. Patient with one type of P2Y12 inhibitor for at least 7 days (i.e. no
- •switching between oral P2Y12 inhibitors has occurred in the previous 7 days)
- •4) If on OAC
- •a. Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for
- •at least 7 days
- •b. Patient is on clopidogrel for at least 7 days
排除标准
- •Patients are not eligible if any of the following applies
- •1) Treated with stents other than Ultimaster stent within 6 months prior to
- •index procedure
- •2) Treated for in-stent restenosis or stent thrombosis at index PCI or within 6
- •months before
- •3) Treated with a bioresorbable scaffold at any time prior to index procedure
- •4) Cannot provide written informed consent
- •5) Under judicial protection, tutorship or curatorship
- •6) Unable to understand and follow study-related instructions or unable to
- •comply with study protocol
- •7) Active bleeding requiring medical attention (BARC>=2) on randomization visit
- •8) Life expectancy less than one year
- •9) Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor,
- •prasugrel, cobalt chromium or sirolimus
- •10) Any planned and anticipated PCI
- •11) Participation in another trial
- •12) Pregnant or breast feeding women
研究者
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