EUCTR2014-005498-35-PL进行中（未招募）1 期
TWLIGHT Study - Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention - TWLIGHT
The Office of Interventional Cardiovascular Research and Clinical Trials at Icahn School of Medicine at Mount Sinai0 个研究点目标入组 9,000 人开始时间: 2016年12月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(MUST MEET AT LEAST ONE):
- •Adult patients = 65 years of age
- •Female gender
- •Troponin positive acute coronary syndrome
- •Established vascular disease defined as previous MI, documented PAD or CAD/PAD revascularization
- •Diabetes mellitus treated with medications (oral hypoglycemic, subcutaneous injection of insulin)
- •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):
- •Multivessel coronary artery disease
- •Target lesion requiring total stent length >30 mm
- •Thrombotic target lesion(s)
- •Bifurcation lesions with Medina X,1,1 classification requiring at least 2 stents
- •Left main (=50%) or proximal LAD (=70%) lesion
- •Calcified target lesion(s) requiring atherectomy
- •*The diagnosis of multivessel CAD may be established with the angiogram performed at enrollment or an earlier angiogram. A vessel previously treated with either a stent or bypass graft may also be considered diseased for purposes of meeting the multivessel CAD angiographic inclusion criterion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3600
排除标准
- •Under 18 years of age
- •Contraindication to aspirin (listed in appendix D)
- •Contraindication to ticagrelor (listed in appendix E)
- •Planned surgery within 90 days
- •Planned coronary revascularization (surgical or percutaneous) within 90 days
- •Need for chronic oral anticoagulation
- •Prior stroke
- •Dialysis-dependent renal failure
- •Active bleeding or extreme-risk for major bleeding (e.g. acute gastrointestinal ulcer or history of chronic gastrointestinal ulceration, gastrointestinal pathology with a raised risk for bleeding, malignancies with a raised risk for bleeding)
- •Salvage PCI or STEMI presentation.
- •Liver cirrhosis
- •Life expectancy < 1 year
- •Unable or unwilling to provide informed consent
- •Women of child bearing potential (as defined in Section 4.2)
- •Fibrinolytic therapy within 24 hours of index PCI
- •Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
- •Platelet count < 100,000 mm3
- •Requiring ongoing treatment with aspirin = 325 mg daily
研究者
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