NL-OMON34026已完成不适用
A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Low Body Weight versus Higher Body Weight Aspirin-Treated Subjects with Stable Coronary Artery Disease - TADI NL (219/101)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eli Lilly
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Participants will include both male and female subjects with stable coronary artery disease (CAD) who are at least 18 years of age and less than 75 years of age (with subjects grouped by body weight, either <60 kg or >=60 kg), and who are not currently indicated for treatment with a thienopyridine. Stable coronary artery disease is defined as any of the following: Subjects diagnosed with chronic stable angina; prior history of unstable angina (including non-ST-segment elevation myocardial infarction) or acute myocardial infarction (AMI); previous coronary revascularisation including percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or CAD in at least one coronary vessel on previous angiography or noninvasive imaging procedure.;The following inclusion criterion is applicable only to patients enrolled at sites in the
- •Netherlands:
- •Subjects previously treated with clopidogrel and aspirin for at least 1
- •year and who did not have a bleeding event requiring medical attention
- •during treatment.
排除标准
- •Unstable coronary artery disease.
- •PCI or CABG within the previous 90 days.
- •History of refractory ventricular arrhythmias within the last 6 months; an implanted defibrillator device; congestive heart failure within 6 months prior to screening; major surgery, or severe trauma, fracture or organ biopsy within 90 days prior to randomisation.
- •Any planned surgical procedure or any coronary revascularisation (surgical or percutaneous) planned within 60 days following randomisation.
- •Any known contraindication to treatment with an antiplatelet agent.
- •Significant hypertension at the time of screening or randomisation.
- •Clinically significant out-of-range values for platelet count or haemoglobin at screening, in the investigator*s opinion, or results of clinical laboratory tests at the time of screening that are judged to be clinically significant for the study population, as determined by the investigator.
- •Prior history or presence of significant bleeding disorders, abnormal bleeding tendency, or personal history of coagulation or bleeding disorders.
- •Prior history or clinical suspicion of cerebral vascular malformations, intracranial neoplasm, transient ischaemic attack (TIA), or stroke.
- •Prior history or presence of thrombocytopaenia or thrombocytosis.
- •Use of antiplatelet agents (excluding aspirin) *10 days prior to screening; the use (or planned use) of heparin, oral anticoagulants, or fibrinolytic agents within 30 days of screening; or subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.;The following exclusion criteria are applicable only to patients enrolled at sites in the
- •Netherlands:
- •- Prior history or presence of decreased kidney function (as defined by
- •creatinine clearance <30 mL/min) and/or a diagnosis of end stage renal
- •disease [ESRD].
- •- Any bleeding requiring medical attention within the last 2 years prior
- •to screening.
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