EUCTR2019-002391-13-IT进行中（未招募）1 期
Platelet inhibition with Ticagrelor 60 mg versus Ticagrelor 90 mg twice daily in elderly patients with acute coronary syndrome (ACS). - Platelet inhibition with Ticagrelor 60 mg versus Ticagrelor 90 mg twice daily in elderly patients wi
AOU FEDERICO II0 个研究点目标入组 50 人开始时间: 2020年10月7日最近更新:
适应症
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
- 50
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.Ability to provide written informed consent in a time window 1 to 3 days after successful PCI;
- •2.Male or female, age = 75 years at screening; ¿
- •3.ACS at the time of the index hospitalization;
- •4.Use of a loading dose of 180 mg of ticagrelor administered after diagnosis of ACS or after PCI;
- •5.Use of a maintenance dose of 90 mg twice daily of ticagrelor of at least 48 hours after the loading dose;
- •6.Successful PCI (Thrombolysis In Myocardial Infarction [TIMI] flow 3 and residual coronary stenosis <30%) for non-ST-segment elevation ACS or ST-segment elevation myocardial infarction
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Use of glycoprotein IIb/IIIa receptor inhibitors;
- •2.Need for chronic oral anticoagulant therapy;
- •3.Prior fibrinolysis;
- •4.Unstable clinical status (hemodynamic or electrical instability);
- •5.Planned surgery requiring DAPT discontinuation during the study;
- •6.Prior stroke, transient ischemic attack or intracranial bleeding;
- •7.Active bleeding;
- •8.Severe anemia (hemoglobin < 8g/dL);
- •9.Platelet count =80x103/ml;
- •10.Renal failure (hemodialysis or creatinine clearance = 30 ml/min calculated with Cockroft- Gault formula);
- •11.Severe hepatic dysfunction (baseline alanine aminotransferase = 2.5 times the upper limit of normal);
- •12.Known hypersensitivity or contraindication to ticagrelor;
- •13. Inhability to sign informed consent;
- •14.Under judicial protection, tutorship or curatorship;
- •15.Unable to understand and follow study-related instructions;
- •16.Enrollment in another investigational device or drug study.
研究者
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