TCTR20211024003招募中3 期
Outcomes of 1-month vs 3-month dual antiplatelet therapy in high bleeding risk patients after percutaneous coronary intervention, a randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 502
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 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •1.All subjects age more than 18 years of age
- •2.diagnosis of acute coronary syndrome (STEMI or NSTEMI) who are acceptable candidates for treatment with a DES.
- •3.The subjects must meet pre-defined ARC-HBR criteria for being high-bleeding risk and are candidates for 1-month DAPT. Patients are considered to be at HBR if at least 1 major or 2 minor criteria are met
排除标准
- •1.Pregnant and breastfeeding women
- •2.Atrial fibrillation
- •3.Subjects requiring a planned PCI procedure after 1 month of index procedure
- •4.Procedure planned to require stand-alone POBA, or stand-alone atherectomy
- •5.Active bleeding at the time of inclusion
- •6.Cardiogenic shock
- •7.Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure
- •8.Subject not expected to comply with long-term single antiplatelet therapy.
- •9.A known hypersensitivity or contraindication to aspirin, heparin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings, stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre- medicated.
- •10.PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
- •11.Participation in another clinical study within 12 months after index procedure
- •12.Subjects with life expectancy of less than 2 years
- •13.History of stent thrombosis on. Antiplatelet treatment
- •14.History of bifurcation stenting with two-stent technique, stenting of last patent vessel
研究者
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