EUCTR2007-005103-18-ES进行中（未招募）不适用
Estudio en fase III, doble ciego, aleatorizado y controlado con placebo, para evaluar los efectos de RO4607381 sobre el riesgo cardiovascular (CV) en pacientes con enfermedad coronaria cardíaca estable que tengan documentado un Síndrome Coronario Agudo (SCA) reciente.A phase III, double-blind, randomized placebo-controlled study, to evaluate theeffects of RO4607381 on cardiovascular (CV) risk in stable CHD patients, with adocumented recent Acute Coronary Syndrome (ACS). - N/A
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, and whose residual cardiovascular risk
- •may benefit from an increase in HDL-C, will be enrolled in this trial. ACS is
- •defined as the occurrence of at least one of the following events:
- •Myocardial Infarction
- •A diagnosis of a qualifying MI event will be defined by abnormal levels of
- •troponin (at least one determination >2x ULN or a set of at least two troponin
- •determinations, drawn at least 6 hours apart, with at least one value elevated
- •between 1 and 2 x ULN and demonstrating a rising or falling pattern) and at least
- •one of the following:
- •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
- •Imaging evidence (eg, echocardiography, radionuclide angiography, singlephoton
- •emission tomography, MRI) of new or presumed new wall motion or
- •perfusion deficit
- •Please note: The preferred biomarker for myocardial necrosis is troponin (I or T).
- •If troponin assays are not available the preferred alternative is CKMB measured
- •by mass assay.
- •When measuring cardiac troponin or CK-MB the ULN should reflect the 99th
- •percentile of distribution in a normal healthy population.
- •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
- 另有 4 项未显示
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 or amenorrhea for 6
- •– 12 months and FSH = 45U/L)
- •3. Symptomatic (NYHA Class II or greater) congestive heart failure requiring
- •and persisting despite appropriate medical treatment at randomization
- •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 Visit 2
- •9. Unexplained creatine phosphokinase levels >3 times the ULN at visit 2
- •10. Serum creatinine > 2.2 mg/dL at Visit 2
- •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 RO4607381 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
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