CTRI/2016/07/007090已完成4 期
Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 610
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Clinical Inclusion Criteria (MUST MEET AT LEAST ONE):
- •1. Adult patients >= 65 years of age
- •2. Female gender
- •3.Troponin positive acute coronary syndrome
- •4. Established vascular disease defined as previous MI, documented PAD or CAD/PAD revascularization
- •5. Diabetes mellitus treated with medications (oral hypoglycemic, subcutaneous injection of insulin)
- •6. Chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2 or creatinine clearance (CrCl) < 60 ml/min
- •Angiographic Inclusion Criteria (MUST MEET AT LEAST ONE):
- •7. Multivessel coronary artery disease
- •8.Target lesion requiring total stent length >30 mm
- •9.Thrombotic target lesion(s)
- •10.Bifurcation lesions with Medina X,1,1 classification requiring at least 2 stents
- •11. Left main (>=50%) or proximal LAD (>=70%) lesion
- •12. Calcified target lesion(s) requiring atherectomy
排除标准
- •Exclusion Criteria:
- •1.Under 18 years of age
- •2.Contraindication to aspirin
- •3. Contraindication to ticagrelor
- •4. Planned surgery within 90 days
- •5. Planned coronary revascularization (surgical or percutaneous) within 90 days
- •6.Need for chronic oral anticoagulation
- •7.Prior stroke
- •8.Dialysis-dependent renal failure
- •9.Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a raised risk for bleeding, malignancies with a raised risk for bleeding)
- •10.Salvage PCI or STEMI presentation.
- •11.Liver cirrhosis
- •12.Life expectancy < 1 year
- •13.Unable or unwilling to provide informed consent
- •14.Women of child bearing potential (as determined by hospital standard of care)
- •Fibrinolytic therapy within 24 hours of index PCI
- •15. Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
- •16.Platelet count < 100,000 mm3
- •17.Requiring ongoing treatment with aspirin >= 325 mg daily
研究者
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