E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051592 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Compare the efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in reducing ApoB/ApoA-I ratio at 3 months in acute coronary syndrome ACS patients receiving the study treatment after a PCI. |
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E.2.2 | Secondary objectives of the trial |
1.The efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in reducing the LDL-C level at 1 month and 3 months in patients receiving the study treatment after a PCI 2.The efficacy of early started rosuvastatin 20 mg versus placebo on hs-CRP from the admission of patients Day 6 until start of study treatment after the PCI Day 0 . 3.The efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in reducing ApoB/ApoA-I ratio at 1 month in patients receiving the study treatment after a PCI |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Provision of written informed consent. 2.Men or women who are 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 4.Percutaneous coronary intervention PCI planned 5.In addition to ischemic symptoms, patients must have evidence of coronary artery disease. |
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E.4 | Principal 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 4 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 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 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 11.Use of concomitant medications, as detailed in Table 4. 12.History of alcohol and/or drug abuse within the past 5 years. 13.Creatine kinase CK 3 x ULN and myocardial isoenzymes CK-MB 2 x ULN at Visit 1. If CK-MB is not available, should be considered CK 3 x ULN and Cardiac Troponin I or T 0 at Visit 1. 14.Systolic hypotension systolic blood pressure SBP 90 mmHg or poorly controlled hypertension SBP 200 mmHg or diastolic blood pressure 110 mmHg recorded since the onset of symptoms. 15.Planned therapeutic coronary intervention other than primary PCI or bypass surgery during the current hospitalization. 16.CABG or percutaneous coronary intervention PCI within the 3 months prior to Visit 1. 17.Occurrence of ventricular fibrillation, sustained ventricular tachycardia, complete heart block, new onset of fibrillation with uncontrolled ventricular rate 100 bpm , or paced ventricular rhythm within the preceding 4 weeks of Visit 1. 18.Stroke, sepsis, acute pericarditis, or any evidence of systemic or pulmonary embolus within the preceding 4 weeks of Visit 1. 19.Known uncontrolled hypothyroidism defined as a thyroid stimulating hormone TSH 1.5 times the upper limit of normal ULN at Visit 1 20.Severe or uncontrolled diabetes Type I or II according to the investigator s judgement. 21.Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the patient s safety or successful participation in the study. 22.Participation in another investigational drug study and/or having ingested investigational drug 61603; 61472;4 weeks, or according to local ethics committee requirements where a larger period is stipulated. 23.Patients already enrolled in the present study. 24.Involvement in the planning and conduct of the study applies to both AstraZeneca staff or staff at the study site |
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E.5 End points |
E.5.1 | Primary end point(s) |
Death Non Fatal Myocardial Infarction Non fatal Stroke Unstable Angina Repeat Revascularization |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |