Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)
Brief Summary: This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (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). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and stroke.


Options:
A: Arm Label: Alirocumab 75 /up to 150 mg Q2W; Type: EXPERIMENTAL; Interventions: Drug: Alirocumab, Drug: Placebo (for ezetimibe), Drug: Lipid Modifying Therapy (LMT) | Arm Label: Ezetimibe 10 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo (for alirocumab), Drug: Ezetimibe, Drug: Lipid Modifying Therapy (LMT) | Intervention Type: DRUG; Name: Alirocumab; Assigned to Arm(s): Alirocumab 75 /up to 150 mg Q2W | Intervention Type: DRUG; Name: Placebo (for alirocumab); Assigned to Arm(s): Ezetimibe 10 mg | Intervention Type: DRUG; Name: Ezetimibe; Assigned to Arm(s): Ezetimibe 10 mg | Intervention Type: DRUG; Name: Placebo (for ezetimibe); Assigned to Arm(s): Alirocumab 75 /up to 150 mg Q2W | Intervention Type: DRUG; Name: Lipid Modifying Therapy (LMT); Assigned to Arm(s): Alirocumab 75 /up to 150 mg Q2W, Ezetimibe 10 mg
B: Arm Label: Pooled subjects who received ezetimibe with simvastatin; Type: EXPERIMENTAL; Interventions: Drug: ezetimibe with simvastatin | Arm Label: Pooled subjects who received simvastatin monotherapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: simvastatin | Intervention Type: DRUG; Name: ezetimibe with simvastatin; Assigned to Arm(s): Pooled subjects who received ezetimibe with simvastatin | Intervention Type: DRUG; Name: simvastatin; Assigned to Arm(s): Pooled subjects who received simvastatin monotherapy
C: Arm Label: ezetimibe/simvastatin; Type: EXPERIMENTAL; Interventions: Drug: ezetimibe/simvastatin, Drug: Placebo for simvastatin 40 mg | Arm Label: simvastatin; Type: ACTIVE_COMPARATOR; Interventions: Drug: simvastatin, Drug: Placebo for simvastatin 40 mg, Drug: Placebo for ezetimibe 10 mg/simvastatin 40 mg combination | Intervention Type: DRUG; Name: ezetimibe/simvastatin; Assigned to Arm(s): ezetimibe/simvastatin | Intervention Type: DRUG; Name: simvastatin; Assigned to Arm(s): simvastatin | Intervention Type: DRUG; Name: Placebo for simvastatin 40 mg; Assigned to Arm(s): ezetimibe/simvastatin, simvastatin | Intervention Type: DRUG; Name: Placebo for ezetimibe 10 mg/simvastatin 40 mg combination; Assigned to Arm(s): simvastatin
D: Arm Label: Extended release niacin; Type: ACTIVE_COMPARATOR; Interventions: Drug: extended release niacin, Drug: ezetimibe | Arm Label: Ezetimibe; Type: ACTIVE_COMPARATOR; Interventions: Drug: ezetimibe | Intervention Type: DRUG; Name: extended release niacin; Assigned to Arm(s): Extended release niacin | Intervention Type: DRUG; Name: ezetimibe; Assigned to Arm(s): Extended release niacin, Ezetimibe

Answer: C