PER-167-08已完成未知
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA•CER)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 13
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（—）
- 性别
- All
入选标准
- •The patient must be at least 18 years of age, be of any sex and ethnicity.
- •Must have a current clinical manifestation of ACS without ST segment elevation
- •The subject must volunteer and have the capacity to give informed consent.
- •Women of childbearing age and sexually active should agree to the use of a medically accepted contraceptive method before selection, while receiving the specific medication from the protocol and during the 2 months following the suspension of the medication.
- •Women of childbearing age and who are not sexually active should agree to the use of a medically accepted contraceptive method in case of starting active sex life while participating in the study
排除标准
- •Simultaneous or anticipated treatment with warfarin (or derivatives, eg fenprocumone [see notes in the document regarding exceptions]), oral factor Xa inhibitor or direct oral thrombin inhibitor after admission
- •simultaneous or anticipated treatment with a potent inducer (eg, rifampin) or a potent inhibitor (eg, ketoconazole, erythromycin) of CYP3A4 isoenzymes (see note in the document regarding exceptions)
- •history of bleeding diathesis or evidence of active abnormal bleeding within 30 days prior to admission
- •history at any time of intracranial hemorrhage, intracranial or spinal cord surgery, or central nervous system tumor or aneurysm
- •severe, prolonged and documented hypertension (systolic blood pressure> 200 mmHg or dystolic blood pressure> 110 mmHg) at the time of admission or during the previous 10 days
- •severe cardiac valvulopathy, as defined by the American College of Cardiology. American Heart Association
- •history, in the 2 weeks prior to admission, of major surgery, excluding those mentioned above or of ischemic stroke (presumably thrombotic)
- •known platelet count <100,000 / mm ^ at the time of admission or during the previous 24 hours
- •known active hepatobiliary disease or known persistent and unexplained increase in serum activity of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) up to twice or more the upper limit of the reference range (^ the upper limit normal ) during the 30 days prior to admission
- •any severe pathology or condition that the investigator considers that (a) could constitute a significant risk for the subject if the study treatment was initiated or (b) could limit the prognosis of the subject, regardless of the study treatment
- •any serious medical comorbidity (eg, active malignancy) that implies that the subject´s life expectancy is <24 months
- •previous participation in this study
- •Current participation in any other research therapy study, or participation in that study within 30 days prior to the present study
- •known hypersensitivity to any component of the medicinal product under investigation
- •breastfeeding, pregnant or pregnant women
- •staff directly involved in this study, or family member of the Research staff.
研究者
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