JPRN-jRCTs042180003已完成4 期
MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus prolonged DAPT regimen - MASTER DAPT
Ozaki Yukio0 个研究点目标入组 189 人开始时间: 2018年9月3日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 189
研究概览
简要总结
One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 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 less than 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 operators 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 met
- •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
- •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 months
- •-Recent (within 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 source)
- •-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 less than 100,000/mm3 (100 x 109/L), or any known coagulation disorder associated with increased bleeding risk.
- •-Documented anaemia defined as repeated haemoglobin levels below 11 g/dl or transfusion within 4 weeks before inclusion.
- •-Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs -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
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
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