KCT0002917招募中未知
Comparison of Tailored Antiplatelet Therapy With Early Escalation and Late DeEscalation Strategy versus Standard Dual Antiplatelet Therapy in Patients Undergoing Complex High-Risk Percutaneous Coronary Intervention
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 2,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •1. Subject was > 19 years of age
- •2. Subjects who scheduled for PCI with contemporary DES
- •3. Patients must have at least one of any features of complex high-risk anatomic, procedural, and clinical-related factors
- •A.Lesion- or procedure-related factors: left main PCI, chronic total occlusion, bifurcation lesion requiring two stent technique, severe calcification, diffuse long lesion (lesion length = at least 30 mm), multi-vessel PCI (= 2 vessels requiring stent implantation), =3 requiring stent implantation, = 3 lesions will be treated, or predicted total stent length for revascularization > 60 mm
- •B.Clinical factors: diabetes, chronic kidney disease (i.e. creatinine clearance <60 mL/min), or severe left ventricular dysfunction (LVEF <40%)
- •4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •1. Enzyme-positive Acute myocardial infarction(NSTEMI or STEMI)
- •2. Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
- •3. Subject using Gp IIb/IIIa inhibitors at randomization
- •4. Cardiogenic shock or Severe LV dysfunction(LV ejection fraction <30%) at the index admission
- •5. Subject treated with only BMS or balloon angioplasty during the index procedure.
- •6. Need for chronic oral anticoagulation (warfarin or NOACs)
- •7. Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)
- •8. History of intracranial hemorrhage or intra cranial aneurysm
- •9. Planned surgery within 180 days
- •10. Subjects with Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening who meet the following criteria
- •1)Platelet count < 80,000 cells/mm3
- •2)Hb <10 g/dL
- •11. Subject at risk of bradycardia (Subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but not inserted permanent pacemaker)
- •12. Subjects taking strong cytochrome P-450 3A inhibitor or inducers within 2 week of the date of enrollment
- •: Ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir, rifampin/rifampicin, rifabutin, dexamethasone, phenytoin, carbamazepine, phenobarbital
- •13. Pregnant and/or lactating women.
- •14. Concurrent medical condition with a life expectancy of less than 1 years
- •15. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •16. Subject was unable to provide written informed consent or participate in long-term follow-up.
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