Ignite Creation Date:
2024-05-05 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00665834
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2008-04-22
Brief Title:
Comparison of Rosuvastatin and Atorvastatin in Patients With Acute Coronary Syndrome
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
Comparison of the Effect Noted in The ApoApo-1 Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome CENTAURUS Study
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 3-month randomized parallel-group study with 2 periods comparing the efficacy and the safety of rosuvastatin 20 mg versus atorvastatin 80 mg in patients with an acute coronary syndrome ACS
Detailed Description:
Patients with ACS acute coronary syndrome constitute a high-risk population with unstable coronary disease CHD that differs from stable CHD primarily in short term prognosis prediction of outcome The 1-year rate of death or non-fatal MI myocardial infarction or heart attack was 13 in patients with ACS in a recent controlled study FRISC II 1999 compared with less than 2 in patients with stable CHD SAPAT 1992 Thus despite substantial progress in the treatment of ACS with antiplatelet and anti-thrombotic medications blood thinners additional therapies are needed to reduce the additional risk associated with unstable CHD Current guidelines NCEP 2001 recommend that patients admitted with a major coronary event MI or ACS should be considered for treatment with a statin on discharge from the hospital
Cited advantages of this approach are patient motivation to start therapy at that time and prevention of a treatment gap due to inconsistent outpatient follow-up A previously randomized controlled study of statin therapy in ACS patients MIRACL study showed that aggressive cholesterol lowering with atorvastatin 80 mg between 24 and 96 hours after hospital admission in patients with ACS resulted in reduced incidence of recurrent CHD events at 16 weeks However the study excluded patients who underwent revascularization PCI Thus the study enrolled only a subset of the ACS population
There is also emerging data from clinical studies supporting the anti-inflammatory actions of statins One recent randomized controlled study demonstrated that statins decrease the levels of CRP considered to be a marker of intra-arterial inflammation and a predictor of recurrent adverse cardiovascular events The relative levels of various lipid measurements such as LDL-C triglycerides and HDL-C probably influence the inflammatory and thrombotic blood clotting properties but the exact relationship is not clear The anti-inflammatory and antithrombotic properties of different statins are likely related to their impact on the lipid profile and their different pleiotropic properties producing more than one genetic effect
The present study is designed to compare the effects of rosuvastatin 20 mg versus atorvastatin 80 mg started at maximum 6 days after an ACS to lipid profile blood cholesterol Additionally the hypothesis of beneficial effect on inflammatory markers compared with statins started later will be tested
c Summary of study design
This is a 3-month randomized parallel-group study with 2 periods comparing the efficacy and the safety of rosuvastatin 20 mg versus atorvastatin 80 mg in patients with an acute coronary syndrome ACS
The study comprises a 1st double blind placebo controlled period that starts at the admission of the patient for an ACS clinical symptoms less than 24 hours until hospital discharge or a maximum timeline of 6 days
The 2nd double blind double dummy period starts at Day 0 ie from the hospital discharge or at a maximum of 6 days after admission and will last 3 months After validation of eligibility criteria including a 1st local assessment of CK creatinine ALT and an ECG and the planning of a PCI between 24 hours and 4 days after admission patients will be randomized into 3 groups
1 early started rosuvastatin 20 mg from admission until the end of the study group 1 - early rosuvastatin 20 mg
2 placebo from admission until Day O ie until hospital discharge or for a maximum of 6 days followed by rosuvastatin 20 mg until the end of the study group 2 - late rosuvastatin 20 mg
3 placebo from admission until Day O ie until hospital discharge or for a maximum of 6 days followed by atorvastatin 80 mg until the end of the study group 3 - atorvastatin 80 mg
Cited advantages of this approach are patient motivation to start therapy at that time and prevention of a treatment gap due to inconsistent outpatient follow-up A previously randomized controlled study of statin therapy in ACS patients MIRACL study showed that aggressive cholesterol lowering with atorvastatin 80 mg between 24 and 96 hours after hospital admission in patients with ACS resulted in reduced incidence of recurrent CHD events at 16 weeks However the study excluded patients who underwent revascularization PCI Thus the study enrolled only a subset of the ACS population
There is also emerging data from clinical studies supporting the anti-inflammatory actions of statins One recent randomized controlled study demonstrated that statins decrease the levels of CRP considered to be a marker of intra-arterial inflammation and a predictor of recurrent adverse cardiovascular events The relative levels of various lipid measurements such as LDL-C triglycerides and HDL-C probably influence the inflammatory and thrombotic blood clotting properties but the exact relationship is not clear The anti-inflammatory and antithrombotic properties of different statins are likely related to their impact on the lipid profile and their different pleiotropic properties producing more than one genetic effect
The present study is designed to compare the effects of rosuvastatin 20 mg versus atorvastatin 80 mg started at maximum 6 days after an ACS to lipid profile blood cholesterol Additionally the hypothesis of beneficial effect on inflammatory markers compared with statins started later will be tested
c Summary of study design
This is a 3-month randomized parallel-group study with 2 periods comparing the efficacy and the safety of rosuvastatin 20 mg versus atorvastatin 80 mg in patients with an acute coronary syndrome ACS
The study comprises a 1st double blind placebo controlled period that starts at the admission of the patient for an ACS clinical symptoms less than 24 hours until hospital discharge or a maximum timeline of 6 days
The 2nd double blind double dummy period starts at Day 0 ie from the hospital discharge or at a maximum of 6 days after admission and will last 3 months After validation of eligibility criteria including a 1st local assessment of CK creatinine ALT and an ECG and the planning of a PCI between 24 hours and 4 days after admission patients will be randomized into 3 groups
1 early started rosuvastatin 20 mg from admission until the end of the study group 1 - early rosuvastatin 20 mg
2 placebo from admission until Day O ie until hospital discharge or for a maximum of 6 days followed by rosuvastatin 20 mg until the end of the study group 2 - late rosuvastatin 20 mg
3 placebo from admission until Day O ie until hospital discharge or for a maximum of 6 days followed by atorvastatin 80 mg until the end of the study group 3 - atorvastatin 80 mg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None