EUCTR2008-004997-41-DE进行中（未招募）不适用
Effectiveness of Prasugrel versus Clopidogrel in Subjects with High Platelet Reactivity on Clopidogrel Following Elective Percutaneous Coronary Intervention with Implantation of Drug-Eluting Stent - TACW
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,250
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] Subjects with coronary artery disease and clinical indication for PCI
- •with implantation of at least one DES, and in whom PCI of all treated
- •lesions is successful (diameter stenosis <30% with TIMI 3 flow in all
- •treated vessels) without major complications (definition s. excl. crit.)
- •One or more bare metal stents (BMS) may be implanted, and other
- •lesions may be treated without stenting, as long as at least one DES is
- •implanted. However, the procedure must be successful and
- •uncomplicated for all lesions (DES + BMS + non stent).
- •[2] Standard of care clopidogrel 600-mg LD must have been given
- •between 24 hours before, and the time of, PCI. A non-study-related
- •standard of care clopidogrel 75-mg MD must have been administered
- •in the morning of the day following PCI. (Administration of an
- •additional non-study-related standard of care clopidogrel 75-mg MD in
- •the evening of PCI should be avoided but is permitted if this is
- •standard of care at the institution).
- •[3] VerifyNow™ PRU >208, measured 2 to 7 hours after a clopidogrel
- •MD received the morning after successful PCI.
- •[4] Aspirin use prior to PCI: A non-study-related dose of at least 250-mg
- •(IV or oral) within 24 hours prior to PCI, and the time of PCI.
- •[5] Only stents that are CE marked for approval may be used in this study.
- •[6] PCI must have been performed with unfractionated or low molecular
- •weight heparin, or bivalirudin as the procedural antithrombin.
- •[7] 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.
- •[8] 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 (based on a urine
- •or serum pregnancy test to be performed before randomization) and
- •agree to use a reliable method of birth control (Pearl Index < 1%)
- •during the study. A highly effective method of birth control is defined
- •as those which result in a low failure rate (i.e., =1% per year)
- •when used consistently and correctly such as implants, injectables,
- •combined oral contraceptives, some IUDs, sexual abstinence or
- •vasectomised partner.
- •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
- •[9] Subjects with non-ST-segment elevation myocardial infarction
- •(NSTEMI) within 14 days prior to randomization. NSTEMI is defined
- •as a history of chest discomfort or ischemic symptoms of =10 minutes
- •duration at rest, with no evidence of persistent ST-segment elevation
- •and with troponin T or I greater than the upper limit of normal (ULN).
- •[10] Subjects with ST-segment elevation myocardial infarction (STEMI)
- •within 14 days prior to randomization. STEMI is defined as a history
- •of chest discomfort or ischemic symptoms of >20 minutes duration at
- •rest with one of the following present on at least one ECG prior to
- •(a) ST-segment elevation =1 mm in two or more contiguous ECG
- •(b) New or presumably new left bundle branch block (LBBB).
- •(c) ST-segment depression =1 mm in two anterior precordial leads
- •(V1 through V4) with clinical history and evidence suggestive of
- •true posterior infarction.
- •[11] Subjects with known major complications after PCI and prior to
- •randomization defined as:
- •(a) ST-segment elevation myocardial infarction (STEMI).
- •(b) Stent thrombosis.
- •(c) Large non-ST-segment elevation myocardial infarction (NSTEMI)
- •defined as an increase in CK >5 x ULN with concomitant rise in
- •(d) Major bleeding at the vascular access site (drop in Hgb of =5g/dL
- •or requiring transfusion).
- •(e) False aneurysma.
- •[12] 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).
- •[13] Have refractory ventricular arrhythmias.
- •[14] Have New York Heart Association (NYHA) Class IV congestive heart
- •failure (CHF; see Attachment TACW.3).
- •[15] Have received fibrin-specific fibrinolytic therapy <24 hours prior to
- •randomization.
- •[16] Have received nonfibrin-specific fibrinolytic therapy <48 hours prior
- •to randomization.
- •[17] Have active internal bleeding or history of major bleeding diathesis.
- •[18] Have clinical findings, in the judgment of the investigator, associated
- •with an increased risk of bleeding.
- •[19] Non-cardiac surgery within 4 weeks prior to PCI.
- •[20] Have any of the following:
- •(a) Prior history of hemorrhagic or ischemic stroke, a transient
- •ischemic attack, or sub-arachnoid hemorrhage.
- •(b) Intracranial neoplasm, arteriovenous malformation, or aneurysm.
- •[21] Have an International Normalized Ratio (INR) >1.5 at the time of
- •evaluation.
- •[22] Have a platelet count of <100,000/mm3 at the time of screening.
- •[23] Have known anemia (Hgb <10 gm/dL) at the time of screening.
- •[24] Have a body weight <60 kg.
- •[25] Have an age of >80 years.
- •[26] Have received GPIIb/IIIa inhibitors eptifibatide or tirofiban within 24
- 另有 13 项未显示
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