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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-002892-34-IT
• Date of registration: 11/10/2006
• Prospective Registration: No
• Primary sponsor: ASTRAZENECA
• Public title: Comparison of the Effects Noted in The ApoB/ApoA-I ratio Using Rosuvastatin and atorvastatin in patients with acUte coronary Syndrome - CENTAURUS STUDY
• Scientific title: Comparison of the Effects Noted in The ApoB/ApoA-I ratio Using Rosuvastatin and atorvastatin in patients with acUte coronary Syndrome - CENTAURUS STUDY
• Date of first enrolment: 26/06/2006
• Target sample size: 1075
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002892-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Estonia, Greece, Hungary, Ireland, Italy, Portugal, Spain

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 AstraZ

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Acute Coronary Syndrome
MedDRA version: 6.1 Level: PT Classification code 10051592

Intervention(s)

Trade Name: CRESTOR*28CPR RIV 20MG

Pharmaceutical Form: Tablet
INN or Proposed INN: Rosuvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: LIPITOR 40*10CPR 40MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Atorvastatin
CAS Number: 134523-03-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Death Non Fatal Myocardial Infarction Non fatal Stroke Unstable Angina Repeat Revascularization

Main Objective: 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.

Secondary Objective: 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

Secondary ID(s)

2005-002892-34-IE

D3560L00052