None listed
Conditions
Interventions
Group 1 Type of group
Ezetimibe/simvastatin 10/40 mg per day from randomization through the end of participation. As per the original protocol, if LDL-C response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped).
Group name:Group 2 Type of group
Simvastatin 40 mg per day from randomization through the end of participation. As per the original protocol, if LDL-C response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped).
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Age
50 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Subjects must meet the following criteria regarding LDL-C concentrations at the time of hospitalization (These criteria must be met for each measurement of LDL-C performed within the first 24 hours of hospitalization): to. Subjects without prior treatment for lipids may be chosen to participate if they have an LDL-C concentration> 50 mg / dl (> 1.3 mmol / l) and 50 mg / dl (> 1.3 mmol / l) and 350 mg / dl (> 4.0 mmol / l) at the time of hospitalization but <1,500 mg / dl (<17.0 mmol / l) , they should obtain a result <350 mg / dl (<4.0 mmol / l) for the TG in the sample obtained on an empty stomach as soon as possible (preferably within 24 hours after hospitalization). • The subjects for whom a PCI is programmed as a treatment for the ACS event that allows entry into the study must perform the PCI before randomization and within 10 days after the initial hospitalization because of the ACS event that allows I entered the study. While subsequent scheduled PCIs are allowed, all scheduled PCIs known at the time of selection must be completed within 30 days after randomization. Whenever possible, PCI (including staggered procedures) that are known to be indicated at the time of selection should be performed before randomization.
Exclusion criteria
Exclusion criteria: • The subject is clinically unstable. A subject is considered to be clinically unstable when he shows any of the following events during the 24 hours prior to selection / randomization: a. Hemodynamic events: (1) hypotension, defined as sustained systolic blood pressure 30 seconds or associated with symptoms; (3) complete heart block; (4) high grade second degree heart block. • The subject is scheduled or a CABG is performed in response to the initial episode of the ACS. • The subject requires the following concomitant medication: cyclosporine, diltiazem, danazol, amiodarone, verapamil, nicotinic acid, fibrates such as concomitant medication or any potent CYP3A4 inhibitor, such as itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, larythromycin inhibitors HIV, nefazodone, probucol, resins,> 1 I of grapefruit juice (grapefruit) per day, torcetrapib and any investigational medication. Antifungal or antibiotic treatment will be accepted provided that the routes of administration are not oral or parenteral (for example, topical, intraocular and otic). Short-term treatment with the prohibited medication will be accepted as long as the medication under study is interrupted during its administration and is restarted once that short-term treatment is completed. • The subject is a pregnant or breastfeeding woman, or a woman who intends to become pregnant. • The subject has active liver disease or persistent and unsubstantiated elevations in serum transaminases (S2 x ULN). If the subject shows transient increases in serum transaminases because of the initial MI, it can be incorporated into the study. • Calculated creatinine removal from the subject (CrCI) is 40 mg; (2) any dose of atorvastatin> 40 mg; (3) any dose of rosuvastatin; (4) any dose of the combination of ezetimibe and simvastatin; and (5) ezetimibe administered together with any dose of a statin. b. For the purposes of this protocol, all other prescription lipid-lowering treatments will be considered to have the same potency or are less potent than simvastatin in doses of 40 mg QD and subjects who follow those treatments may participate in this study. • The subject was previously incorporated into the present study under Protocol No. P04103.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular death, major coronary Event (non-fatal myocardial infarction [MI], documented unstable angina [UA] requiring hospitalization, or coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) ≥ 30 days after randomization), or non-fatal Stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced cardiovascular death, major coronary event, or non-fatal stroke within 7 years from randomization. Measure:Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) Timepoints:Up to approximately 9 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: death from any cause, major coronary event (non-fatal myocardial infarction, documented unstable angina requiring hospitalization, or coronary revascularization with percutaneous coronary intervention or coronary artery bypass grafting ≥ 30 days after randomization), or non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, major coronary event, or non-fatal stroke within 7 years from randomization. Measure:Time to First Occurrence of Death From Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) Timepoints:Up to approximately 9 years ; Outcome name:The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization within 7 years from randomization. Measure:Time to First Occurrence | — |
Countries
Peru, United States
Contacts
Public Contactreyes richard
WorldWide Clinical Trials Peru S.R.L. -W.C.T. Peru S.R.L.
Outcome results
None listed