Comparison of the Effects Noted in The ApoB/ApoA-I ratio Using Rosuvastatin and atorvastatin in patients with acUte coronary Syndrome. - CENTAURUS

AstraZeneca SAS0 个研究点目标入组 1,150 人2006年5月26日

适应症Men or women who are >18 and <75 years old diagnosed with non ST elevation - acute coronary syndrome (NSTE-ACS) and onset of clinical symptoms less than 24 hours at the admission for which a PCI is planned or anticipated. Patients with STEMI and primary PCI planned within 24 hours of admission will not be included. Patients will not be allowed to have taken any cholesterol-lowering medications during 1 month prior to enrolment.

相关药物Crestor Em Portugal: Zarator 40 mg

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Men or women who are >18 and <75 years old diagnosed with non ST elevation - acute coronary syndrome (NSTE-ACS) and onset of clinical symptoms less than 24 hours at the admission for which a PCI is planned or anticipated. Patients with STEMI and primary PCI planned within 24 hours of admission will not be included. Patients will not be allowed to have taken any cholesterol-lowering medications during 1 month prior to enrolment.
发起方: AstraZeneca SAS
入组人数: 1150
状态: 进行中（未招募）
最后更新: 14年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2006年5月26日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

AstraZeneca SAS

入排标准

入选标准

•This is a study of non\-STE patients with ACS admitted to hospital within 24 hours of symptoms onset who will be scheduled for a Percutaneous Coronary Intervention (PCI) for treatment of the index event according to the local or European Guidelines for PCI (Silber S. 2005\). Non\-STE ACS patients include those with unstable angina and non\-STE MI (Cannon et al 2001\). See Appendix G.
•For inclusion into the randomised treatment phase of the study, patients must fulfil all of the following criteria:
•1\.Provision of written informed consent.
•2\.Men or women who are ³ 18 and £ 75 years old.
•3\.Hospital admission for ACS with chest pain or discomfort occurring during rest or with minimal exertion, relieved by nitroglycerin or lasting for at least 15 minutes if untreated, and with the most recent occurrence \< 24 hours before hospital admission (ischemic symptoms). The presenting symptoms must represent a change from the patient’s usual angina pattern (more frequent, longer in duration or lower in threshold).
•4\.Percutaneous coronary intervention (PCI) planned or anticipated for treatment of the index event, 2 days (\-1/\+2 days) after ACS symptoms and according to local or the European Guidelines for PCI (Silber S. 2005\).
•5\.In addition to ischemic symptoms (described above), patients must have evidence of coronary artery disease. This may include any of the following findings:
•oDocumented previous MI
•oAngiographic evidence of coronary artery disease
•oIschemic ECG changes, i.e. new or dynamic ST segment depression or T wave inversion in 2 or more contiguous electrocardiographic leads: at least 0\.5 mm horizontal or down\-sloping ST depression at the J point or up\-sloping ST segment depression that remains at least 1 mm depressed 80 ms after the J point, or at least 1 mm T\-wave inversion.

排除标准

•1\.History of statin induced myopathy, or serious or hypersensitivity reaction to other HMG\-CoA reductase inhibitors (statins).
•2\.Known homozygous familial hypercholesterolemia.
•3\.Any cholesterol lowering medication (HMG\-CoA reductase inhibitors, fibrates, niacin (\> 400 mg/day), ezetimibe, bile acid sequestrants, probucol or other prescription medications used to treat dyslipidemia) (Table 5\) taken within 1 month prior to the Visit 1\. Patients taking lipid lowering dietary supplements, anti\-oxidants, or food additives may continue at their current dose. No new lipid lowering dietary supplements, anti\-oxidants or food additives should be started for the duration of the study.
•4\.Pregnant women, women who are breast\-feeding, and women of childbearing potential who are not using chemical or mechanical contraception, or who have a positive serum pregnancy test (serum b\-HCG).
•5\.Sustained ST\-segment elevation on 12\-lead ECG
•6\.Active liver disease or hepatic dysfunction or alanine aminotransferase (ALT) elevation of ³ 2 x ULN
•7\.Serum creatinine \> 2\.0 mg/dL (176 mmol/L).
•8\.LDL\-C £ 40 mg/dL (1\.03 mmol/L) or triglycerides ³ 400 mg/dL (4\.52 mmol/L)
•9\.Patients whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated within the 3 months prior to the Visit 1\.
•10\.History of malignancy (unless a documented disease\-free period exceeding 5 years is present) with the exception of basal cell or squamous cell carcinoma of the skin. Women with a history of cervical dysplasia would be permitted to enter the study provided they have 3 consecutive clear Papanicolaou (Pap) smears