EUCTR2004-000023-15-FI进行中（未招募）1 期
A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects who are to Undergo Percutaneous Coronary Intervention - TRITON; TIMI 38; TAA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 14,200
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
- •Subjects are eligible to be included in the study only if they meet all of the following
- •[1] Present with acute coronary syndrome based on the disease
- •diagnostic criteria and are to undergo percutaneous coronary
- •intervention (PCI).
- •[2] Are of a legal age (and at least 18 years of age) and competent mental
- •condition to provide written informed consent before entering the
- •study. Informed consent must be signed by the study participant or
- •authorized representative, according to local rules and regulations.
- •[3] For women of child-bearing potential only (that is, women who are not
- •surgically or chemically sterilized and who are between menarche and
- •1 year postmenopause), test negative for pregnancy between ACS
- •presentation and enrollment (based on a urine or serum pregnancy test)
- •and agree to use a reliable method of birth control during the study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •Cardiovascular Exclusion Criteria
- •[4] Have cardiogenic shock
- •[5] Have refractory ventricular arrhythmias.
- •[6] Have NYHA Class IV congestive heart failure
- •Bleeding Risk Exclusion Criteria
- •[7] Have received fibrin-specific fibrinolytic therapy <24 hours prior to randomization.
- •[8] Have received nonfibrin-specific fibrinolytic therapy <48 hours prior to randomization.
- •[9] Have active internal bleeding or history of bleeding diathesis.
- •[10] Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
- •[11] Have any of the following:
- •a) Prior history of hemorrhagic stroke.
- •b) Intracranial neoplasm, arteriovenous malformation, or aneurysm.
- •c) Ischemic stroke =<3 months prior to screening.
- •[12] Have an INR known to be >1.5 at the time of evaluation.
- •[13] Have a platelet count of <100,000/mm3 at the time of screening.
- •[14] Have anemia (hemoglobin <10 g/dL) at the time of screening.
- •Prior/Concomitant Therapy Exclusion Criteria
- •[15] Have received one or more doses of a thienopyridine =<5 days prior to PCI.
- •[16] Are receiving or will receive oral anticoagulation or other antiplatelet therapy that cannot be safely discontinued for the duration of the study.
- •[17] Are receiving daily treatment with NSAIDs or COX2 inhibitors that cannot be discontinued or are anticipated to require >2 weeks of daily treatment with NSAID or COX2 inhibitors during the study.
- •General Exclusion Criteria
- •[21] Have previously completed or withdrawn from this study or any other
- •study investigating CS-747.
- •[22] Are women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
- •[23] Have a concomitant medical illness (for example, terminal malignancy) that in the opinion of the investigator is associated with reduced survival over the expected treatment period (maximum of 15 months).
- •[24] Have known severe hepatic dysfunction (i.e. cirrhosis or portal hypertension).
- •[25] Have a condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence.
- •[26] Have a history of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine or clopidogrel).
研究者
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