CTRI/2011/05/001713Other3 期
Evaluation of the Safety and Efficacy of Short-term A-002 Treatment in Subjects with Acute Coronary Syndromes.
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 6,500
- 试验地点
- 16
- 主要终点
- To determine whether 16 weeks oftreatment with A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the hazard of the first occurrence of the combined endpoint of cardiovascular death, non fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.
研究概览
简要总结
This is a double-blind, randomized, parallel group, placebo controlled study in subjects presenting with an ACS. Up to 6500 subjects will be randomized to receive either A-002 500 mg once daily (QD) or placebo tablets in addition to atorvastatin QD and standard of care. Treatment will be 16 weeks in duration. The dose of atorvastatin shall be adjusted after 8 weeks if LDL-C of subject is more than or equal to 100 mg/dL, but otherwise must remain stable throughout the16-week duration of study. The survival status for all enrolled subjects will be ascertained 6 months after they complete the study. Randomization must occur within less than or equal to 96 hours of hospitalization for the index ACS event, or if already hospitalized, within 96 hours of index event diagnosis. Follow-up visits occur at 1, 2, 4, 6, 24, 48, 72 and 96 and Weeks 1, 2, 4, 8 and 16. Randomization will be stratified by the presence or absence of lipid-altering therapy prior to the index event as well as the type of index event (admission diagnosis of unstable angina, NSTEMI or STEMI). The number of subjects who undergo PCI following the index event and prior to randomization will be limited to no more than 55% of the total study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 0.00 Day(s)（—）
- 性别
- All
入选标准
- •Men and women equal and above 40 years of age
- •A diagnosis of unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (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, new or dynamic ST-segment depression or prominent T-wave inversion changes in at least 2 contiguous leads. 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
- •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 greater than or equal to 150 mg/dL (greater than or equal to 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 greater than or equal to 130/85 mmHg.
- •Plasma glucose greater than or equal to 110 mg/dL (greater than or equal to 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
- •Subjects must be randomized within less than or equal to 96 hours of hospital admission for the index event, or if already hospitalized, within less than or equal to 96 hours of index event diagnosis
- •Revascularization, if required or planned, must occur prior to randomization.
排除标准
- •Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to Screening.
- •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)
- •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)
- •Active cholecystitis, gall bladder symptoms, or any hepatobiliary abnormalities
- •The presence of severe renal impairment (creatinine clearance [CrCl] 30 mL/min or creatinine 3 x ULN), nephrotic syndrome, or subjects undergoing dialysis
- •Uncontrolled diabetes mellitus (known hemoglobin A1c [HbA1c] 11% within the last 1 month prior to Screening)
- •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).
- •Subjects who have a history of alcohol or drug abuse within 1 year of study entry
- •Subjects living too far from participating center or unable to return for follow-up visits
- •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
- •Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection
- •Acute bacterial, fungal or viral infection
- •Subjects currently taking drugs that are potent inhibitors of cytochrome P450 unless they can be withdrawn
- •Subjects with New York Heart Association (NYHA) Class III or IV heart failure, or if known, left ventricular ejection fraction (LVEF) 30%
- •Subjects with moderate or severe aortic stenosis, aortic regurgitation, mitral stenosis or mitral regurgitation
- •Ventricular arrhythmias requiring chronic drug treatment or implantable cardioverter-defibrillator (ICD)
- •Subjects with no stenosis or stenosis 50% on angiography, if known
- •Subjects with a pacemaker or persistent left bundle branch block (LBBB)
- •Subjects who have a history of statin intolerance or a significant myopathy or rhabdomyolysis with any lipidaltering drugs
- •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.
结局指标
主要结局
To determine whether 16 weeks oftreatment with A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the hazard of the first occurrence of the combined endpoint of cardiovascular death, non fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.
时间窗: 16 Weeks
次要结局
- To determine whether A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the occurrence of the hazard of the combined endpoint of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization, or multiple occurrences of the non-fatal components of the composite primary endpoint.(16 Weeks)
研究者
研究点 (16)
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