CTRI/2010/091/000348已完成2 期
A Comparison of Platelet Inhibition Following a Prasugrel 60 mg or Prasugrel 30 mg Loading Dose With or Without Pretreatment With a Clopidogrel Loading Dose in Acute Coronary Syndrome Patients Who Are to Undergo Percutaneous Coronary Intervention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Eli Lilly
- 入组人数
- 210
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
入选标准
- •Present with acute coronary syndrome (ACS) consisting of unstable angina (UA), Non ST-elevated myocardial infarction (NSTEMI)or ST-elevated myocardial infarction (STEMI) and are to undergo percutaneous coronary intervention (PCI).
- •-Provide written informed consent (ICD) by participant or authorized representative
- •-Weigh at least 60 kilograms at the time of screening.
- •-For women of child-bearing potential (that is, women who are not surgically or chemically sterilized and who are between menarche and 1 year postmenopause), test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test and agree to use a reliable method of birth control during the study.
- •-Sign ICD for mandatory genetic testing.
排除标准
- •Cardiovascular Exclusion Criteria
- •-Have cardiogenic shock at the time of randomization (systolic blood pressure >90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion.
- •-Have refractory ventricular arrhythmias
- •-Have New York Heart Association (NYHA) Class IV congestive heart failure
- •-Have systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 100 mm Hg.
- •-Have received fibrin-specific fibrinolytic therapy <24 hours prior to randomization.
- •-Have received nonfibrin-specific fibrinolytic therapy <48 hours prior to randomization.
- •-Have active internal bleeding or history of bleeding diathesis.
- •-Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
- •-Prior history of ischemic or hemorrhagic stroke.
- •-Intracranial neoplasm, arteriovenous malformation, or aneurysm.
- •-Prior history of transient ischemic attack (TIA).
- •-Have an International Normalized Ratio (INR) known to be >1.5 at the time of evaluation.
- •-Have a platelet count of <100,000/mm3 at the time of screening.
- •-Have anemia (hemoglobin [Hgb] <10 gm/dL) at the time of screening.
- •-Prior/Concomitant Therapy Exclusion Criteria
- •-Have received one or more doses of a thienopyridine (ticlopidine or clopidogrel) £10 days prior to PCI.
- •-Are receiving GPIIb/IIIa during their index admission.
- •-Are receiving or will receive oral anticoagulation or other antiplatelet therapy, other than aspirin (ASA), that cannot be safely discontinued for the duration of the study.
- •-Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (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
- •-Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •-Have previously completed or withdrawn from this study or any other study investigating prasugrel.
- •-Are women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
- •-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.
- •-Have known severe hepatic dysfunction (that is, with cirrhosis or portal hypertension).
- •-Have a history of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine or clopidogrel).
- •-May be unable to cooperate with protocol requirements and follow-up procedures.
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