EUCTR2009-016812-18-HU进行中（未招募）不适用
Evaluation of the Safety and Efficacy of Short-term A-002 Treatment in Subjects with Acute Coronary Syndromes - VISTA-16
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6,504
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
- •1. Men and women =40 years of age
- •2. Written informed consent from the subject
- •3. A diagnosis of unstable angina, NSTEMI, or STEMI
- •Unstable angina is defined as:
- •. Chest pain symptomatic of ischemia or angina occurring at rest or on minimal exertion with a pattern of increasing frequency or severity, lasting >10 minutes and consistent with myocardial ischemia within 24 hours prior to hospitalization and
- •. New or dynamic ST-segment depression or prominent T-wave inversion changes in at least 2 contiguous leads and
- •. In addition subjects meeting the above criteria for unstable angina must also have either troponin I, troponin T or CK-MB above the LLD but below the 99th percentile of the upper reference limit (URL) and not due to cardioversion or underlying cardiovascular (CHF, cardiomyopathy) or renal disease.
- •NSTEMI is defined as:
- •. Chest pain symptomatic of ischemia
- •. No electrocardiogram (ECG) changes, or ST-depression, or T wave changes (i.e., no new Q waves on serial ECGs) and
- •. Increase in cardiac troponin > local limit for the definition of myocardial infarction or increase in CK-MB isoenzyme > URL
- •STEMI is defined as:
- •. Chest pain symptomatic of ischemia
- •. ST segment elevation and associated T wave changes or ST-segment elevation of at least 2 mm in 2 contiguous leads, either of which persisting for longer than 15 minutes and
- •. Increase in cardiac troponin > local limit for the definition of myocardial infarction or increase in CK-MB >URL
- •4. All subjects (unstable angina, NSTEMI, or STEMI) must have the presence of at least one of the following risk factors:
- •i. Diabetes Mellitus* or
- •ii. Presence of any 3 of the following characteristics of metabolic syndrome
- •. Waist circumference >102 cm in males, >88 cm in females
- •. Serum triglycerides =150 mg/dL (=1.7 mmol/L)
- •. HDL-C <40 mg/dL (<1 mmol/L) in males, <50 mg/dL (<1.3 mmol/L) in females
- •. Blood pressure =130/85 mmHg
- •. Plasma glucose =110 mg/dL (=6.1 mmol/L) or
- •iii. history of cerebrovascular disease (stroke or TIA) or
- •iv. history of peripheral vascular disease or
- •v. previous CABG or
- •vi. previous documented myocardial infarction or
- •vii. previous coronary revascularization
- •5. Subjects must be randomized within =96 hours of hospital admission for the index event, or if already hospitalized, within =96 hours of index event diagnosis
- •6. Revascularization, if required or planned, must occur prior to randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to Screening.
- •2. Subjects treated for cancer within the previous 5 years except for skin basal cell carcinoma or carcinoma in situ of the cervix, with measures other than a minor, complete surgical excision or radiation therapy (e.g. chemotherapy)
- •3. The presence of any severe liver disease with cirrhosis, active hepatitis, active chronic hepatitis, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN, biliary obstruction with hyperbilirubinemia (total bilirubin >2 x ULN)
- •4. Active cholecystitis, gall bladder symptoms, or any hepatobiliary abnormalities
- •5. The presence of severe renal impairment (creatinine clearance [CrCl] <30 mL/min or creatinine >3 x ULN), nephrotic syndrome, or subjects undergoing dialysis
- •6. Uncontrolled diabetes mellitus (known hemoglobin A1c [HbA1c] >11% within the last 1 month prior to Screening)
- •7. Females who are nursing, pregnant, or intend to become pregnant during the time of the study, or females of childbearing potential who have a positive pregnancy test during screening evaluation. Women of child-bearing potential must also use a reliable method of birth control during the study and for 1 month following completion of therapy. A reliable method for this study is defined as one of the following: oral or injectable contraceptives, intrauterine device (IUD), contraceptive implants, tubal ligation, hysterectomy, a double barrier method (diaphragm with spermicidal foam or jelly, or a condom).
- •8. Subjects who have a history of alcohol or drug abuse within 1 year of study entry
- •9. Subjects living too far from participating center or unable to return for follow-up visits
- •10. Subjects who in the opinion of the Investigator are a poor medical or psychiatric risk for therapy with an investigational drug, are unreliable, or have an incomplete
- •understanding of the study which may affect their ability to take drugs as prescribed or comply with instructions
- •11. Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection
- •12. Acute bacterial, fungal or viral infection
- •13. Subjects currently taking drugs that are potent inhibitors of cytochrome P450 unless they can be withdrawn
- •14. Subjects with New York Heart Association (NYHA) Class III or IV heart failure, or if known, left ventricular ejection fraction (LVEF) <30 not due to myocardial stunning or hibernation
- •15. Subjects with moderate or severe aortic stenosis, aortic regurgitation, mitral stenosis or mitral regurgitation
- •16. Ventricular arrhythmias requiring chronic drug treatment or implantable cardioverter-defibrillator (ICD)
- •17. Subjects with no stenosis or stenosis <50% on angiography, if known
- •18. Subjects with a pacemaker or persistent left bundle branch block (LBBB)
- •19. Fasting triglyceride levels of =400 mg/dL (4.5 mmol/L)
- •20. Subjects who have a history of statin intolerance or a significant myopathy or rhabdomyolysis with any lipidaltering drugs
- •21. Subjects currently treated with the maximum labeled dose of a statin and not at LDL-C target for their level of risk as defined by NCEP ATP III
研究者
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