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临床试验/NCT03445273
NCT03445273Unknown不适用

Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery

Italian Society of Invasive Cardiology5 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2018年11月21日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,800
试验地点
5
主要终点
Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery

研究概览

简要总结

The MONET registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure. The effects of the application of the Consensus Document "Stent and Surgery-2" on perioperative antiplatelet therapy will be assessed. The study will also assess ischemic and hemorrhagic events in relation to the application of the Consensus Document and length of any antiplatelet discontinuation and delay in performing surgical procedures.

详细描述

The MONET registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure at the participating Centers. Centers will be divided into two groups: Centers that routinely follow the recommendations of the SAS 2 Document and Centers that do not. The relevant clinical, procedural and outcome data (within index admission and at 30 days) will be entered in a specifically designed electronic case record form (eCRF). The primary endpoint will be the rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 3 months after PCI with low risk characteristics and 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy. The secondary end-point will be the composite of death, myocardial infarction, probable/definite stent thrombosis and bleeding events at 30 days; the type and the length of discontinuation of any antiplatelet therapy in patients undergoing surgery according to time from PCI to surgery; delay in performing surgical procedure; rate of surgical procedures within 12 months from PCI divided into quartiles (0-3, 3-6, 6-9, 9-12 months).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible will be male and female patients > 18 years of age.
  • Eligible will be patients with previous coronary stenting undergoing any kind of surgical or operative endoscopic procedure at the participating Centers, irrespective of the distance in time between stenting and surgery.
  • Both candidates to elective and urgent/emergent surgical procedures will be included in the MONET registry.

排除标准

  • Unwillingness/inability to sign the Informed Consent Form (ICF). Patients with an active bleeding requiring discontinuation of one or both antiplatelet agents will be also excluded. There are no other exclusion criteria.

结局指标

主要结局

Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery

时间窗: 6 months

Rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy

次要结局

未报告次要终点

研究者

发起方
Italian Society of Invasive Cardiology
申办方类型
Other
责任方
Sponsor

研究点 (5)

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