NL-OMON55786已完成3 期
A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dacetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-GenE trial - dal-GenE
DalCor Pharma UK Ltd0 个研究点目标入组 276 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 276
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects with the appropriate genetic background and recently hospitalized for
- •ACS (between 1 and 3 months following the index event), will be enrolled in
- •this trial. ACS is defined as the occurrence of at least one of the following
- •A) 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:
- •a. Symptoms of myocardial ischemia, or
- •b. New or presumed new significant ST-segment-T wave (ST-T) changes or new left
- •bundle branch block, or
- •c. Development of pathological Q waves in the ECG, or
- •d. Imaging evidence of new loss of viable myocardium or new regional wall
- •motion abnormality, or
- •e. 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:
- •a. Symptoms suggestive of myocardial ischemia
- •b. New ischemic ECG changes
- •c. Imaging demonstration of new loss of viable myocardium or new regional wall
- •motion abnormality
- •d. Angiographic findings consistent with a procedural complication
- •B) 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 23hrs) with
- •symptoms presumed to be caused by myocardial ischemia with an accelerating
- •tempo in the prior 48hrs and/or prolonged (at least 20min) 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:
- •a. At least 50% stenosis of an epicardial coronary artery
- •b. Positive exercise or pharmacologic stress indicating reversible ischemia
- •c. Presence of pathologic Q-waves on ECG
- •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 obtained prior to any study specific screening
- •3. AA genotype at variant rs1967309 in the ADCY9 gene as determined by cobas®
- •ADCY9 Genotype CTA testing, conducted at a designated investigational testing
- •4. Clinically stable, ie, free of ischemic symptoms at rest or with minimal
- •exertion for at least 1 week prior to randomization
- •5. Prior to randomization, subject must have evidence of guidelines-based
- •management of LDL-C, at a minimum to include medical and dietary treatment to a
- •target level of LDL-C <100mg/dl (<2.6mmol/L). Subjects with an LDL-C level
- •*100mg/dl (*2.6mmol/L) may be randomized if they cannot reach the target goal
- •of less than 100mg/dl despite lipid-lowering regimen, or are unable to tolerate
- •lipid-lowering regimen.
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 child-bearing potential (women who are not surgically sterile or
- •postmenopausal defined as amenorrhea for >12 months) who are not using at least
- •one method of contraception.
- •3. New York Heart Association (NYHA) Class III or IV heart failure
- •4. Last known hemoglobin <10g/dl
- •5. Index ACS event presumed due to uncontrolled hypertension
- •6. Systolic blood pressure (BP) >180mmHg and/or diastolic blood pressure
- •>110mmHg by the time of randomization despite anti-hypertensive therapy
- •7. Last known serum triglyceride level >500mg/dl (>5.65mmol/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 > 2.2mg/dl (195*mol/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
- •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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