EUCTR2014-005498-35-AT进行中（未招募）1 期
TWILIGHT Study - Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention - TWILIGHT
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1月11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
入选标准
- •Must meet AT LEAST ONE clinical inclusion criterion:
- •- 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 or insulin
- •- Chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 or creatinine clearance (CrCl) <60 ml/min
- •Must meet AT LEAST ONE angiographic inclusion criterion:
- •- Multivessel coronary artery disease (CAD) *
- •- Target lesion requiring total stent length >30mm
- •- Thrombotic target lesion(s)
- •- Bifurcation lesion(s) 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
- •Subjects should not enter the study if any of the following exclusion criteria are met:
- •- Under 18 years of age
- •- Contraindication to aspirin
- •- Contraindication to ticagrelor
- •- 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 below:
- •A woman is considered of childbearing potential (WOBCP) following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is
- •defined as no menses for 12 months without an alternative medical cause.
- •- 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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