EUCTR2006-000296-15-BE进行中（未招募）不适用
A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Clinical Events and Biomarkers in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •Men and women (women of child-bearing potential must use adequate contraception)
- •Presenting with features of non-ST segment elevation ACS (unstable angina or MI without persistent ST elevation). There must be new onset or a worsening pattern of characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than 5 minutes or requiring sublingual nitroglycerin for relief of the pain)
- •Randomisation and treatment possible within 72 hours of the onset of symptoms. Every effort should be made to randomise and treat eligible subjects as soon after hospital admission as possible.
- •Age 18–80 years inclusive and at least one of the following two criteria on admission:
- •- Troponin T or I = ULN or CKMB = ULN for the local institution
- •- ECG changes compatible with ischemia (i.e. ST depression at least 1 mm in 2 contiguous leads or T wave inversion > 3 mm or any dynamic ST shift or transient ST elevation)
- •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
- •Unwilling or unable to provide informed consent
- •History of acquired or congenital bleeding disorder, coagulopathy or platelet disorder
- •Recent trauma or major surgery (within the 30 days prior to screening/baseline)
- •Recent (within 14 days prior to screening/baseline) significant infection or history of chronic infections with a recurrence < 14 days prior to screening/baseline visit and/or requiring continuous antibiotic treatment
- •Evidence of active pathological bleeding at screening/baseline or history of bleeding (such as gastrointestinal or genitourinary) within the last 6 months prior to screening/baseline visit, unless the cause has been definitely corrected
- •History of intracranial bleeding e.g. hemorrhagic stroke, subdural hematoma, subarachnoid hemorrhage) or history of hemorrhagic retinopathy
- •History of ischemic stroke or transient ischemic attack, within the past year prior to screening/baseline or known structural cerebral vascular lesion (eg, arteriovenous malformation [AVM], aneurysm)
- •Haematological abnormalities: platelet count <100 x 103 / µL, haemoglobin < 10 g/dL at screening/baseline visit (day 1)
- •History of NYHA class III or IV congestive heart failure or history of severe, uncontrolled cardiac arrhythmias at screening/baseline
- •Patients with ST-segment changes at baseline attributed to left ventricular hypertrophy with repolarisation changes, bundle branch block and digoxin will be excluded.
- •Percutaneous cardiac intervention or coronary artery surgery in the previous 12 weeks prior to the current hospital admission.
- •Significant (as determined by the investigator) cardiovascular events (such as a Q wave MI) within the past 30 days prior to the screening/baseline visit
- •Planned elective surgical operation or major invasive procedures planned from 30 days prior to screening to completion of the study (the decision of what constitutes a major invasive procedure will be at the discretion of the investigator in conjunction with review and approval by the Medical Monitor)
- •Unstable diabetes requiring frequent adjustments to medications (other than insulin) in the 30 days prior to the screening/baseline visit
- •Documented history of chronic liver disease and/or screening/baseline ALT or AST > 3 x ULN or total bilirubin > 1.5 x ULN (unless the abnormal bilirubin is secondary to Gilbert’s syndrome)
- •History of rheumatologic or autoimmune diseases
- •Significant renal impairment, defined as creatinine clearance of < 30mL/min
- •History of cancer (other than basal cell carcinoma, cervical carcinoma in situ, or low-grade prostate cancer), unless adequately treated with no evidence of disease recurrence for at least 2 years
- •Use of any of the following drugs in the 30 days prior to the screening / baseline visit and for the duration of the study:
- •-Oral antiplatelets other than aspirin (daily aspirin dose of 325 mg or lower) and/or clopidogrel (75 mg chronically; loading dose allowed) and/or Ticlopidine (250mg BID)
- •-Oral anticoagulants (e.g. acenocoumarol, warfarin)
- •-Fibrinolytics (eg, tPA, streptokinase, urokinase)
- •-NSAIDs, (including COX-2 inhibitors) other than occasional use
- •-Potent and moderate CYP 3A4 inhibitors
- •-Selected CYP 2D6 substrates
- •-Herbals with anti-platelet properties:Gingko biloba, Horse chestnut (Aesculus hippocastanum)
- •Use of another investigational drug or device within previous 30 days (12 weeks for investigational devices, eg, unapproved stents) prior to sceening/baseline visit
- •Pregnant or nursing
研究者
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