EUCTR2014-001661-27-ES进行中（未招募）1 期
Comparison of TIcagrelor and clopidogrel in patients with Coronary artery diseaSe and type 2 Diabetes Mellitus (TICS-DM): a randomized pharmacodynamic study - TICS-DM
Sociedad Española de Cardiología0 个研究点开始时间: 2014年10月16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
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
- •1. Provision of informed consent prior to any study specific procedures
- •2. Age between 18 and 75 years
- •3. Type 2 diabetes mellitus according to ADA criteria
- •4. Angiographically documented coronary artery disease
- •5. Chronic treatment (>1 month) with aspirin (100mg/day)
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Known allergies to aspirin, clopidogrel, or ticagrelor
- •2. Blood dyscrasia or bleeding diathesis
- •3. Any recent acute coronary syndrome (<30 days) or hemodinamic instability
- •4. Recent antiplatelet therapy (<14 days), with the exception of ASA, including: thienopyridines, cilostazol, dipiridamol, glycoprotein IIb/IIIa inhibitors
- •5. Oral anticoagulation with a coumarin derivative
- •6. Any active bleeding
- •7. Recent history of stroke, transient ischemic attack or intracranial bleeding (<6 months prior to inclusion)
- •8. Platelet count <100x106/microl
- •9. Any active neoplasm
- •10. Severe chronic kidney disease (creatinine clearance measured with Cockcroft-Gault formula <30ml/min)
- •11. Baseline ALT >2.5 times the upper limit of normality
- •12. Pregnant or childbearing females
研究者
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