NL-OMON34002已完成2 期
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 - LANCELOT 202
PRA Belgium BVBA0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
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 symptoms. Every effort should be made to randomize 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
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 /
- •*L, 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.
- •* A marked prolongation of QT/QTc interval (>500 ms) at the screening/baseline visit (Day 1)
- •* Percutaneous cardiac intervention or coronary artery surgery in the previous 12 weeks
- •prior to the screening/baseline visit
- •* 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 lowgrade
- •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:
- •o Oral anti-thrombotics 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)
- •o Anticoagulants (e.g. coumadin, warfarin)
- •o Fibrinolytics (eg, tPA, streptokinase, urokinase)
- •o NSAIDs, other than occasional use
- •o COX-2 inhibitors (other than occasional use)
- •o Potent and moderate CYP (global) 3A4
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