EUCTR2015-003895-65-GB进行中（未招募）1 期
A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-GenE trial - dal-GenE trial
DalCor Pharma UK Ltd, Stockport, Swiss Branch Zug0 个研究点目标入组 6,000 人开始时间: 2016年10月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,000
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
- •Subjects with the appropriate genetic background and recently hospitalized for ACS (between 4 and 12 weeks following the index event), will be enrolled in this trial. ACS is defined as the occurrence of at least one of the following events:
- •Myocardial Infarction (MI)
- •Spontaneous MI
- •A diagnosis of a qualifying MI event will be defined by a rise and/or fall of cardiac biomarkers (preferably cardiac troponin) with at least one determination greater than the 99th percentile upper reference limit (URL) plus at least one of the following described below:
- •Symptoms of myocardial ischemia, or
- •New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block, or
- •Development of pathological Q waves in the ECG, or
- •Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality, or
- •Identification of an intracoronary thrombus by angiography
- •Procedure-Related MI after Percutaneous Coronary Intervention (PCI)
- •A procedure-related MI after PCI is defined as an increase of cardiac troponin values with at least one determination greater than 5 times the 99th percentile URL in patients with normal baseline values (less than or equal to 99th percentile URL) or a rise of cardiac troponin values > 20% if the baseline values are elevated and are stable or falling; plus at least one of the following described below:
- •Symptoms suggestive of myocardial ischemia
- •New ischemic ECG changes
- •Imaging demonstration of new loss of viable myocardium or new regional wall motion abnormality
- •Angiographic findings consistent with a procedural complication
- •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:
- •at least 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 of at least 0.5mm in at least 2 contiguous leads or T wave inversion of at least 1mm in leads with predominant R wave or R/S >1 in at least 2 contiguous leads
- •New or presumed new ST elevation at the J point in = 2 contiguous leads with the following 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 left bundle branch block (LBBB)
- •New tall R wave of at least 40ms in V1 and/or 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 at least 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 subjects age 45 years and over at screening visit (V1)
- •2. Signed informed consent (approved by Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures
排除标准
- •1. Females who are pregnant (negative pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
- •2. Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not simultaneously using two effective contraceptive methods, and one of which being a barrier method (diaphragm, cervical cap, male condom, etc.)
- •3. New York Heart Association (NYHA) Class III or IV heart failure
- •4. Last known hemoglobin <10 g/dL
- •5. Index ACS event presumed due to uncontrolled hypertension
- •6. Systolic blood pressure (BP) >180 mmHg and/or diastolic blood pressure >110 mmHg by the time of randomization despite anti-hypertensive therapy
- •7. Last known serum triglyceride level > 500 mg/dL (> 5.65 mmol/L) as assessed within 6 months prior to randomization
- •8. Last known hemoglobin A1c (HbA1c) >10% as assessed within 6 months prior to randomization
- •9. Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis
- •10. Last known ALT or AST level > 3 times the upper limit of normal (ULN) or last known alkaline phosphatase level > 2 times the ULN as assessed within 6 months prior to randomization (excluding index event)
- •11. History of persistent and unexplained creatine phosphokinase (CPK) levels > 3 times the ULN as assessed within 6 months prior to randomization (excluding index event)
- •12. Last known serum creatinine > 2.2 mg/dL (195 µmol/l) as assessed within 6 months prior to randomization
- •13. Previous exposure to anacetrapib or evacetrapib or documented allergic reaction to any CETP inhibitor
- •14. History of malignancy (except for curatively treated basal cell or squamous cell carcinoma of the skin) during the 1 year prior to the screening
- •15. Any clinically significant medical condition that according to the investigator could interfere with the conduct of the study
- •16. Subjects whose life expectancy is shorter than 3 years
- •17. Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient’s successful participation in the study
- •18. Current alcohol or drug abuse or history thereof within 2 years prior to screening that would likely interfere with compliance, based on investigator assessment
- •19. Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial
- •20. Subjects unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study
- •21. Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization
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