EUCTR2017-001834-25-IT进行中（未招募）1 期
MAnagement of high bleeding risk patients post bioresorbable polymercoated STEnt implantation with an abbReviated versus prolonged DAPTregimen – MASTER DAPT - MASTER DAPT
ECRI-90 个研究点目标入组 4,300 人开始时间: 2020年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 be
- •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
- •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
- •Definition of HBR
- •Post-PCI patients are at HBR if at least one of the following criteria applies:
- •¿ Clinical indication for treatment with oral anticoagulants (OAC) for at least 12
- •¿ Recent (<12 months) non-access site bleeding episode(s), which required
- •medical attention (i.e. actionable bleeding).
- •¿ Previous bleeding episode(s) which required hospitalization if the underlying
- •cause has not been definitively treated (i.e. surgical removal of the bleeding
- •¿ Age equal or greater than 75 years
- •¿ Systemic conditions associated with an increased bleeding risk (e.g.
- •haematological disorders, including a history of or current thrombocytopaenia
- •defined as a platelet count <100,000/mm3 (<100 x 109/L), or any known
- •coagulation disorder associated with increased bleeding risk.
- •¿ Documented anaemia defined as repeated haemoglobin levels <11 g/dl or
- •transfusion within 4 weeks before inclusion.
- •¿ Need for chronic treatment with steroids or non-steroidal anti-inflammatory
- •¿ Diagnosed malignancy (other than skin) considered at high bleeding risk
- •including gastro-intestinal, genito-urethral/renal and pulmonary.
- •¿ Stroke at any time or TIA in the previous 6 months
- •¿ PRECISE DAPT score of 25 or greater
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 430
- 另有 2 项未显示
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
- •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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