Comparison of the Effects Noted in The ApoB/ApoA-I ratio Using Rosuvastatin and atorvastatin in patients with acUte coronary Syndrome.Comparación de los Efectos Observados en el cociente ApoB/ApoA-I, tras el Uso de Rosuvastatina y Atorvastatina en pacientes con Síndrome Coronario Agudo - CENTAURUS - CENTAURUS

AstraZeneca SAS0 sites1,150 target enrollmentOctober 4, 2005

ConditionsMen 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.

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: 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.
Sponsor: AstraZeneca SAS
Enrollment: 1150
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 4, 2005

End Date

October 8, 2007

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

AstraZeneca SAS

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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