EUCTR2015-002040-14-DE进行中（未招募）1 期
A Phase III Multi-Center, Double-Blind, Randomized, Parallel Group, Placebo- Controlled Clinical Trial in High-Risk Type 2 Diabetes Mellitus (T2DM) Subjects with Coronary Artery Disease (CAD) to Determine Whether Bromodomain Extraterminal Domain(BET) Inhibition Treatment with RVX000222 Increases the Time to Major Adverse Cardiovascular Events (MACE) - BETonMACE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,400
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
入选标准
- •1. Male and female subjects age 18 and over with documented diagnosed T2DM and a CAD event of either unstable angina or myocardial infarction, not less than 7 days and no more than 90 days prior to Visit 1. In order to have sufficient number of clinical events, the number of subjects with unstable angina will be limited to 25% of the total number of subjects
- •- Unstable angina: for a qualifying unstable angina event, each of components (a), (b), and (c) must be satisfied:
- •a. Characteristic ischemic pain or discomfort in chest or associated referral areas, occurring at rest or with minimal exertion
- •b. ECG changes consistent with acute myocardial ischemia based upon at least one of the following:
- •i. new or presumed new ST elevation
- •ii. new or presumed new ST depression
- •iii. new or presumed new T-wave inversion
- •c. Objective evidence of obstructive coronary artery disease based upon at least one of the following:
- •i. new or presumed new evidence of myocardial ischemia or infarction by perfusion imaging
- •ii. new or presumed new regional wall motion abnormality
- •iii. current evidence of at least one epicardial coronary artery stenosis = 70% by coronary angiography
- •iv. need for coronary revascularization for the index ACS event including percutaneous coronary intervention (PCI) with or without coronary stenting
- •- Previous MI 7-90 days before screening treated with or without a percutaneous coronary intervention (PCI). For a qualifying event of MI, two of the following three criteria must be satisfied:
- •a. Characteristic ischemic chest pain or pain in associated referral areas
- •b. Dynamic elevation of troponin T or I or CKMB, if troponin T or I is unavailable at the local lab (at least above the upper limit of normal for the laboratory)
- •c. Development of new Q-waves in at least two adjacent ECG leads, or development of a new dominant R wave in V1
- •2. Documented diagnosis of T2DM (one or more of the following criteria must be met):
- •- Documented history of T2DM
- •- History of taking diabetes medication
- •- HbA1c >6.5% at Visit 1
- •3. For males HDL-C of <40 mg/dL (1.04 mmol/L) and for females HDL-C of <45 mg/dL (1.17 mmol/L) at Visit 1.
- •4. In the opinion of the Investigator, subjects currently not on high intensity statin therapy will be able to start rosuvastatin according to the protocol at Visit 1.
- •5. In the opinion of the Investigator, subjects currently on statin therapy other than atorvastatin or rosuvastatin can be switched to rosuvastatin according to the protocol at Visit 1. High intensity statin therapy doses should remain unchanged during the study period if at all possible.
- •6. Female subjects must meet one of the following:
- •a. If of childbearing potential, female subjects must have a negative urine pregnancy test and be willing and able to use medically acceptable non-hormonal method of birth control (nonhormonal
- •intrauterine device, condom, or diaphragm) or remain abstinent from Screening until Follow-up Visit.
- •b. Be of non-child-bearing potential: post-surgical sterilization or post-menopausal.
排除标准
- •1. Heart disease which, in the opinion of the investigator, will within 90 days of Visit 1 likely require coronary bypass, PCI, cardiac transplantation, surgical repair and/or replacement.
- •2. Previous or current diagnosis of severe heart failure (New York Heart Association Class IV) or a documented left ventricular ejection fraction (LVEF) of <25% as determined by contrast left ventriculography, radionuclide ventriculography or echocardiography. The absence of an LVEF measurement in a subject without a previous or current diagnosis of heart failure does not prohibit entry into the study.
- •3. Subjects with evidence of cardiac electrophysiologic instability including a history of uncontrolled ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular
- •tachycardias with a ventricular response heart rate of >100 beats per minute at rest within 4 weeks prior to Visit 1.
- •4. Coronary artery bypass grafting (CABG) within 90 days prior to Visit 1.
- •5. Evidence of severe renal impairment as determined by any one of the following:
- •- an estimated Glomerular Filtration Rate less than 30 mL/min/1.7m2 at Visit 1
- •- a current need for dialysis
- •6. Uncontrolled hypertension defined as 2 consecutive measurements of sitting blood pressure of systolic >180 mm Hg or diastolic >100 mm Hg at Visit 1.
- •7. Current or recent (within 12 months prior to Visit 1) treatment with immunosuppressants (e.g., cyclosporine).
- •8. Use of fibrates at any dose or niacin/nicotinic acid 250 mg or more within 30 days prior to Visit 1.
- •9. A known allergy or sensitivity to any ingredient in the investigational medicinal product.
- •10. History of intolerance to atorvastatin or rosuvastatin. This exclusion criterion applies to subjects with a history of intolerance to the statin to which they would be assigned at screening.
- •11. Triglycerides >400 mg/dL (4.52 mmol/L) at Visit 1.
- •12. Any medical or surgical condition which might significantly alter the absorption, distribution, metabolism or excretion of medication including, but not limited to, any of the following: Untreated or incompletely treated thyroid dysfunction, cholecystitis, Crohn’s disease, ulcerative colitis, or any gastric bypass alteration.
- •13. Evidence of cirrhosis from liver imaging or biopsy, a history of hepatic encephalopathy, esophageal or gastric varices, active hepatitis, or prior porta-caval shunt procedure, or a Child- Pugh score of at least 5 points (Appendix A)
- •- Any one of the following liver enzymes that is >1.5xULN by central lab at Visit 1
- •14. A total bilirubin that is >ULN by central lab at Visit 1
- •15. History of malignancy of any organ system, treated or untreated, within the past 2 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- •16. History or evidence of drug or alcohol abuse within 12 months of Visit 1, in the opinion of the investigator.
- •17. Female subjects who are pregnant.
- •18. Any condition which, in the opinion of the investigator, may place the subject at hig
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