Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An International, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-segment Elevation MI Acute Coronary Syndromes
Brief Summary: Study Objectives

PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9 in the acute treatment of patients with unstable angina/non ST-segment elevation myocardial infarction concurrently managed with standard medical therapy.

SECONDARY OBJECTIVE: If non inferiority of fondaparinux is established on initial statistical analysis in a second step, superiority of fondaparinux to enoxaparin will be evaluated statistically.

* To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at Day 9
* To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding events up to Day 9
* To determine whether the relative effect on the primary end point of fondaparinux versus enoxaparin is sustained at Day 14, Day 30, Day 90 and Day 180

Study Drug: Patients will be randomized to receive either:

* Fondaparinux 2.5 mg once and placebo-enoxaparin twice daily by subcutaneous injection or
* Enoxaparin (1mg/kg) twice and fondaparinux-placebo once daily by subcutaneous injection

Duration of Therapy:

* Fondaparinux 2.5mg daily for 8 days or hospital discharge (whichever is earlier)
* Enoxaparin 1mg/kg b.i.d. x 2-8 days or until clinically stable.
* Patients should receive an ASA and all other standard medical therapies.

Substudy:

* A substudy comparing routine early coronary angiography immediately or as soon as possible (but no later than 24 hours after randomization) and intervention versus delayed (\>48 hrs) coronary angiography and intervention.

Primary Outcome: The first occurence of any component of the following composite up to Day 9:

* Death
* Myocardial Infarction
* Refractory Ischemia


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Device: Intraaortic Balloon Pump | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Device: Left Ventricular Assist Device Impella LP 2.5 | Intervention Type: DEVICE; Name: Left Ventricular Assist Device Impella LP 2.5; Assigned to Arm(s): 2 | Intervention Type: DEVICE; Name: Intraaortic Balloon Pump; Assigned to Arm(s): 1
B: Arm Label: IMPELLA LP 2.5; Type: EXPERIMENTAL; Interventions: Device: IMPLELLA LP 2.5 | Arm Label: IABP Intra-aortic balloon pump; Type: ACTIVE_COMPARATOR; Interventions: Device: IABP Intra-aortic balloon pump | Intervention Type: DEVICE; Name: IMPLELLA LP 2.5; Assigned to Arm(s): IMPELLA LP 2.5 | Intervention Type: DEVICE; Name: IABP Intra-aortic balloon pump; Assigned to Arm(s): IABP Intra-aortic balloon pump
C: Arm Label: Enoxaparin; Type: ACTIVE_COMPARATOR; Interventions: Drug: enoxaparin | Arm Label: Fondaparinux; Type: EXPERIMENTAL; Interventions: Drug: Fondaparinux | Intervention Type: DRUG; Name: Fondaparinux; Assigned to Arm(s): Fondaparinux | Intervention Type: DRUG; Name: enoxaparin; Assigned to Arm(s): Enoxaparin
D: Arm Label: Elective IABP Insertion; Type: EXPERIMENTAL; Interventions: Device: Intra-Aortic Balloon Pump | Arm Label: No Planned IABP Insertion; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Intra-Aortic Balloon Pump; Assigned to Arm(s): Elective IABP Insertion

Answer: C