EUCTR2005-001556-20-CZ进行中（未招募）不适用
Integrated Biomarker and Imaging Study – 2 (IBIS-2) - IBIS-2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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. Signed written informed consent prior to beginning study-related procedures (subject must understand the aims, investigational procedures and possible consequences of the study).
- •2. Male or female aged 18 to 80 years of age at screening. Female subjects of
- •childbearing potential must be willing to follow contraceptive measures (described in
- •Appendix 3 of study protocol).
- •3. Successful percutaneous coronary intervention (PCI) defined as placement of bare
- •metal or drug eluting stent in the native coronary arteries
- •Uncomplicated diagnostic cardiac catheterization in subjects in whom no PCI is
- •Important: approximately =50% of randomized subjects must present with ACS and
- •evidence of myocardial necrosis (i.e., STEMI or NSTEMI). ACS is defined as a history
- •of chest pain (or chest pain equivalent) lasting = 20 minutes that occurred within 72 hours prior to the qualifying IVUS and the presence of elevated concentrations of cardiac biomarkers (troponins). Pre-catheterization Troponin must be assessed at both central and local laboratories and determined to be >99th percentile of the values for a reference control group to qualify as evidence of myocardial necrosis. The central laboratory Troponin I value will be used for the purpose of analyses.
- •4. Baseline IVUS of the non-intervened coronary arterial segment recorded according
- •to protocol-mandated criteria that contains a lesion with less than 50% stenosis by
- •visual inspection on angiography (refer to IBIS-2 Study Manual: – Imaging Procedures and Measurements [Core Imaging Laboratory, 2005])
- •5. Must be receiving at least one oral antiplatelet agent (e.g., aspirin, clopidogrel) at
- •time of randomization.
- •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
- •Clinical and laboratory exclusion criteria:
- •1. Evidence of clinical instability or new abnormal clinical laboratory findings post-PCI
- •or post cardiac catheterization but prior to randomization that in opinion of the
- •investigator makes the subject unsuitable for the study.
- •2. History of CABG surgery.
- •3. Planned cardiac surgery (e.g., CABG, valve repair or replacement) or planned major
- •non-cardiac surgery within the study period.
- •4. Stroke or resuscitated cardiac arrest in the past 6 months.
- •5. QTc interval >440msec (males) or >450msec (females) at Screening
- •6. History of chronic viral hepatitis (including hepatitis B surface antigen or hepatitis C
- •antibody) or other chronic hepatic disorder. ALT or AST >2.5 x upper limit of normal or alkaline phosphatase or total bilirubin >1.5 x upper limit of normal at Screening.
- •7. Renal impairment with serum creatinine >2.0 mg/dL (177umol/L) or calculated creatinine clearance <40 mL/min/1.73 m2 at Screening (based on MDRD Study equation [Levey, 1999]), or history of kidney transplant, or history of contrast nephropathy.
- •8. Current inadequately controlled hypertension (blood pressure >160 mmHg systolic
- •and/or >100 mmHg diastolic) on a stable dose of antihypertensive medication.
- •9. Recent use (within < 1 month) or currently receiving transdermal, oral, inhaled, or
- •injectable corticosteroids.
- •10. Current poorly controlled diabetes mellitus, defined as HbA1c >10% at Screen.
- •11. History of severe heart failure defined as NYHA class III or IV or known severe left ventricular (LV) dysfunction (ejection fraction [EF]<30%) regardless of symptomatic status.
- •12. History of adult asthma manifested by bronchospasm in the past 6 months, or
- •currently taking regular anti-asthmatic medication(s).
- •13. History of anaphylaxis, anaphylactoid reactions or severe allergic responses within the past 6 months.
- •14. History of malignancy within the past 5 years, other than non-melanoma skin cancer.
- •15. Current life-threatening condition other than vascular disease (e.g., very severe
- •chronic airways disease, HIV positive, life-threatening arrhythmias) that may prevent
- •a subject from completing the study.
- •16. Alcohol or drug abuse within the past 6 months.
- •17. Currently receiving oral or injectable potent CYP3A4 inhibitor(s). Subjects should be instructed to refrain from consumption of > 240mL daily of grapefruit-juice, which may inhibit CYP3A4.
- •18. Previous exposure to SB-480848.
- •19. Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication.
- •20. Pregnancy (defined as a positive pregnancy test by serum ß-HCG) or lactation at
- •21. Any subject the investigator deems unsuitable for the study (e.g., due to medical
- •reasons, laboratory abnormalities, expected study medication noncompliance, or unwillingness or inability to comply with all study-related procedures).
- •Anatomical exclusion criteria:
- •22. Left main coronary artery stenosis >50% by visual inspection of coronary angiogram.
- •23. Luminal diameter of the study vessel <2.5 mm by visual inspection of coronary
- •24. Severe tortuousity of the study vessel or any other relevant anatomical reasons (e.g., heavy calcifications) that the investigator deems inappropriate for IVUS study.
研究者
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