NL-OMON34504尚未招募3 期
Evaluation of the Safety and Efficacy of Short-term A 002 Treatment in Subjects with Acute Coronary Syndromes - VISTA-16
Anthera Pharmaceuticals, Inc0 个研究点目标入组 576 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 576
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Men and women *40 years of age
- •2. Written informed consent from the subject
- •3. All subjects must have the presence of at least one of the following risk
- •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
- •- history of cerebrovascular disease (stroke or TIA) o
- •- HDL <42 mg/dL or
- •- eGFR <60 mL/min or
- •- angiographic evidence of CAD (>50%)
- •- history of peripheral vascular disease or
- •- previous CABG or
- •- previous documented myocardial infarction or
- •- previous coronary revascularization
- •4. 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
- •5. Percutenous revascularization, if required or planned, must occur prior to randomization
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 hepato-biliary
- •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 child-bearing potential who have a
- •positive pregnancy test during screening evaluation. Women of childbearing
- •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 followup visits
- •10. Subjects who have a history of statin intolerance or a significant myopathy or rhabdomyolysis with any lipid-altering drugs
- •11. 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
研究者
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