EUCTR2007-005103-18-CZ进行中（未招募）不适用
A phase III, double-blind, randomized placebo-controlled study, to evaluate theeffects of dalcetrapib on cardiovascular (CV) risk in stable CHD patients, with adocumented recent Acute Coronary Syndrome (ACS). - dal-OUTCOMES
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15,600
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
- •Patients recently hospitalized for ACS (between 4 and 12 weeks after index event), and whose residual cardiovascular risk
- •may benefit from an increase in HDL-C as assessed by the investigator, will be enrolled in this trial. ACS is
- •defined as the occurrence of at least one of the following events:
- •Myocardial Infarction
- •- Spontaneous Myocardila Infarction
- •A diagnosis of a qualifying MI event will be defined by abnormal levels of cardiac biomarkers (troponin I or T or CK-MB mass) with at least one determination > the 99th percentile or upper limits of normal for the laboratory and at least
- •one of the following described below. Symptoms of myocardial ischemia within 48 hours prior to the MI
- •New ECG findings (or presumed new if no prior ECG available) as described below
- •Loss of viable myocardium based on imaging evidence of new or presumed new wall motion of perfusion deficit (eg. echocardiography, left ventriculography during cardiac catheterization radionuclide angiography, singlephoton
- •emission tomography, MRI)
- •Procedure-Related Myocardial Infarction after PCI
- •Patients experiencing a myocardial infarction after a PCI will also be included in this study. A procedure-related MI after PCI is defined as follows:
- •Normal biomarkers (eg. CK-MB or troponin I or T) before the procedure and biomarkers after procedure elevated to > 3 times the 99th percentile or upper limits of normal for the laboratory.
- •Hospitalization for ACS (ECG Abnormalities without Biomarkers):
- •A diagnosis of a qualifying ACS event without increases in cardiac biomarkers
- •will require admission to hospital or emergency room (exceeding 23 hrs) with
- •symptoms presumed to be caused by myocardial ischemia with an accelerating
- •tempo in the prior 48 hrs and/or prolonged (at least 20 min) rest chest discomfort
- •and new ECG findings (or presumed new if no prior ECG available) as described
- •below and at least one of the following:
- •50% stenosis of an epicardial coronary artery;
- •positive exercise or pharmacologic stress indicating reversible ischemia;
- •presence of pathologic Q-waves on ECG
- •Examples of New ECG findings include:
- •New or presumed new ST depression > 0.5mm in 2 contiguous leads or T
- •wave inversion > 1mm in leads with predominant R wave or R/S >1 in 2
- •contiguous leads.
- •New or presumed new ST elevation at the J point in = 2 contiguous leads
- •with the cut-off points: = 0.2mV in men or = 0.15mV in women in leads V2-
- •V3 and/or =0.1 mV in other leads or new or presumed new LBBB
- •New tall R wave > 40ms in V1,V2 and R/S = 1 in V1 with concordant
- •positive T-wave in the absence of a conduction defect.
- •New Q waves = 30 ms wide and > 1mm deep in any 2 leads of a contiguous
- •lead grouping or Q wave >20ms or QS complex in leads V2 and V3 (These
- •criteria also apply to silent MI detected during a routine follow-up visit)
- •In addition, the following inclusion criteria apply:
- •1. Both male and female patients able and willing to give written informed
- •2. Age 45 and over at Visit 1
- •3. Signed informed consent (approved by Institutional Review Board
- •[IRB]/Independent Ethics Committee [IEC]) obtained prior to any study
- •specific screening procedures
- •4. Clinically stable, ie, free of ischemic symptoms at rest or with minimal
- •exertion for at least 1 week prior to randomization
- •5. Triglycerides < 400 mg/dL (<4.5 mmol/L) at Visit 2
- •6. Evidence-based management of LDL-C cholesterol, at a minimum to include
- •medical and dietary treatment to a target level of <100 mg/dl (<2.6 mmol/L)
排除标准
- •1. Females who are pregnant or breast-feeding
- •2. Women of child bearing potential (women who are not surgically sterile or
- •post-menopausal defined as amenorrhea for > 12 months) who are not using a highly contraceptive method (failure rates less than 1% per year) such as implants, injectibles, combined oral contraceptives or hormonal intrauterine devices (IUDs). In addition, a negative serum pregnancy test must be available before starting the run-in period.
- •3. Symptomatic (NYHA Class II or greater) congestive heart failure requiring
- •and persisting despite such treatment at the end of the run-in period. Patients with NYHA Class II heart failure symptoms may be included if a measurement of left ventricular function is performed and ejection fraction is shown to be > 40%.
- •4. Severe anemia defined as hemoglobin = 10 g/L at Visit 2
- •5. Index ACS event presumed due to uncontrolled hypertension and/or systolic
- •blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg by
- •the end of the placebo run-in period despite anti-hypertensive therapy
- •6. Hemoglobin A1c >10% at Visit 2
- •7. Patients with clinically apparent liver disease, eg, jaundice, choleastasis,
- •hepatic synthetic impairment, or active hepatitis
- •8. Hepatic transaminase, alkaline phosphatase or total bilirubin levels >1.5 times
- •the ULN at the end of the run-in period.
- •9. Unexplained creatine phosphokinase levels >3 times the ULN at visit 2
- •10. Serum creatinine > 2.2 mg/dL (194.5 umol/l) at the end of the run-in period.
- •11. Concomitant treatment with niacin, fibrates, bile acid sequestrants, or
- •riminabant. Treatment with ezetimibe or fish oil derivatives is permitted.
- •12. Concomitant treatment with any drug other than dalcetrapib administered for
- •the purpose of increasing levels of HDL-C.
- •13. Previous exposure to torcetrapib or any other CETP inhibitor as for example
- •14. History of malignancy (except for curatively treated basal cell or squamous
- •cell carcinoma of the skin) during the 3 years prior to the screening.
- •15. Any clinically significant medical condition that according to the investigator
- •could interfere with the conduct of the study.
- •16. Patients whose life expectancy is shorter than duration of the trial
- •17. Presence of any laboratory abnormality performed prior to randomization that
- •is considered by the investigator to be clinically important.
- •18. Current alcohol or drug abuse or history thereof within 5 years prior to
- •19. Patients exposed to RO4607381 within the last 12 months before the start of
- •20. Subjects who have received any investigational drug or device within 1
- •month of visit 1, or who expect to participate in any other investigational drug
- •or device study during the conduct of this trial
- •21. Unable or unwilling to comply with protocol requirements, or deemed by the
- •investigator to be unfit for the study
研究者
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