Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Large Scale Clinical Trial Testing the Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic Congestive Heart Failure
Brief Summary: INTRODUCTION While pharmacological treatments specifically targeted to the cardio-circulatory system have been largely investigated, scanty controlled data are available concerning the role of dietary and metabolic approaches in the management/outcome of patients with heart failure. A large scale, randomized, clinical trial is proposed to test the effects of (a) n-3 PUFA and (b) a lipid lowering agent on top of the best recommended treatments for heart failure.

STUDY DESIGN

The GISSI-HF is a prospective, multicenter, randomized, double blind, placebo controlled study, with randomized allocation of patients with a clinical diagnosis of heart failure to:

Randomization 1 (R1): n-3 PUFA 1 g daily vs corresponding placebo; Randomization 2 (R2): rosuvastatin 10 mg daily vs corresponding placebo.

OBJECTIVES OF THE STUDY PRIMARY OBJECTIVES

To demonstrate that, in patients with heart failure treated at the best of recommended therapies, long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than the corresponding placebo in the reduction of:

* All-cause mortality
* All-cause mortality or hospitalizations for cardiovascular reason

OTHER END-POINT MEASURES OF EFFICACY

To assess that long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than corresponding placebo in the reduction of:

* Cardiovascular mortality
* Cardiovascular mortality or hospitalizations for any reason
* Sudden cardiac death
* Hospitalizations for any reason
* Hospitalizations for cardiovascular reasons
* Hospitalizations for congestive heart failure
* Myocardial infarction
* Stroke


Options:
A: Arm Label: Olmesartan medoxomil; Type: ACTIVE_COMPARATOR; Interventions: Drug: olmesartan medoxomil | Arm Label: Standard therapy; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: olmesartan medoxomil; Assigned to Arm(s): Olmesartan medoxomil
B: Arm Label: Aggrenox, Clopidogrel placebo, Micardis; Type: PLACEBO_COMPARATOR; Interventions: Drug: Aggrenox, Drug: Clopidogrel placebo, Drug: Micardis | Arm Label: Aggrenox placebo, clopidogrel,, Micardis; Type: PLACEBO_COMPARATOR; Interventions: Drug: Micardis, Drug: Aggrenox placebo, Drug: Clopidogrel | Arm Label: Aggrenox, clop placebo, micardis placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Aggrenox, Drug: Clopidogrel placebo, Drug: Micardis placebo | Arm Label: Aggrenox plcebo, clop, micardis placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Aggrenox placebo, Drug: Clopidogrel, Drug: Micardis placebo | Intervention Type: DRUG; Name: Aggrenox; Assigned to Arm(s): Aggrenox, Clopidogrel placebo, Micardis | Intervention Type: DRUG; Name: Aggrenox; Assigned to Arm(s): Aggrenox, clop placebo, micardis placebo | Intervention Type: DRUG; Name: Clopidogrel placebo; Assigned to Arm(s): Aggrenox, Clopidogrel placebo, Micardis | Intervention Type: DRUG; Name: Clopidogrel placebo; Assigned to Arm(s): Aggrenox, clop placebo, micardis placebo | Intervention Type: DRUG; Name: Micardis; Assigned to Arm(s): Aggrenox, Clopidogrel placebo, Micardis | Intervention Type: DRUG; Name: Micardis; Assigned to Arm(s): Aggrenox placebo, clopidogrel,, Micardis | Intervention Type: DRUG; Name: Aggrenox placebo; Assigned to Arm(s): Aggrenox placebo, clopidogrel,, Micardis | Intervention Type: DRUG; Name: Aggrenox placebo; Assigned to Arm(s): Aggrenox plcebo, clop, micardis placebo | Intervention Type: DRUG; Name: Clopidogrel; Assigned to Arm(s): Aggrenox placebo, clopidogrel,, Micardis | Intervention Type: DRUG; Name: Clopidogrel; Assigned to Arm(s): Aggrenox plcebo, clop, micardis placebo | Intervention Type: DRUG; Name: Micardis placebo; Assigned to Arm(s): Aggrenox, clop placebo, micardis placebo | Intervention Type: DRUG; Name: Micardis placebo; Assigned to Arm(s): Aggrenox plcebo, clop, micardis placebo
C: Arm Label: Initial presentation of coronary disease - Stable angina; Type: N/A; Interventions: N/A | Arm Label: Initial presentation of coronary disease - ACS; Type: N/A; Interventions: N/A | Arm Label: Initial presentation of coronary disease - Coronary death; Type: N/A; Interventions: N/A | Arm Label: Initial presentation of coronary disease - None; Type: N/A; Interventions: N/A
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: n-3 PUFA | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Rosuvastatin | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: n-3 PUFA; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 4

Answer: D