Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* Acute coronary syndrome (ACS/AMI) \< 48h and cardiogenic shock defined as:

  * Clinical criteria: Hypotension (syst.BP \< 90 mmHg and HR \> 90/min or an AV- Block II-III) or the need for positive inotropic drugs to maintain BB \> 90mm Hg)and end-organ hypoperfusion
  * Hemodynamic criteria: CI \< 2.2 L/min/qm and a PCWP \> 15 mmHg or an EF of LV \< 30% and LVEDP \> 20 mmHg.
* Written informed consent of the patient or his/hers relatives

Exclusion Criteria:

* Age \< 18 years
* Prolonged Resuscitation (\> 30min)
* Hypertrophic Obstructive Cardiomyopathy
* Thrombus in left ventricle
* Treatment with IABP
* Severe valvular disease or mechanical heart valve
* Cardiogenic Shock due to mechanical complications of myocardial infarction such as VSD, acute mitral regurgitation \>II°, rupture of the ventricle
* Failure of the right ventricle defined as the need for a RV Assist Device
* Septic condition
* Cerebral Disease
* Bleeding with a need for surgical intervention
* Pulmonary embolism
* Allergy to Heparin or any known coagulopathy
* Aortic regurgitation \>II°
* Pregnancy
* Inclusion in another study or trial
B: Inclusion Criteria:

* Informed consent
* Subject is indicated for a NON emergent percutaneous treatment of at least on de novo or restenotic lesion in a native coronary vessel or bypass graft.
* Patient presents with:

  * A compromised Ejection Fraction
  * Intervention on the last patent coronary conduit
  * Intervention on an unprotected left main artery or
  * Patient presenting with triple vessel disease.

Exclusion Criteria:

* ST elevation M.I.
* Pre procedure cardiac arrest within 24 hours.
* Subject in cardiogenic shock
C: Inclusion Criteria:

* Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome.
* Able to randomize within 24 hours of the onset of the most recent episode of symptoms.
* At least one of the following additional criteria: (1) Troponin T of I or CK-MB above the upper limit of normal for the local institution and/or (2) ECG changes compatible with ischemia
* Written informed consent

Exclusion Criteria:

* Age \< 21 years
* Any contraindication to low molecular weight heparin
* Hemorrhagic stroke within the last 12 months
* Indication for anticoagulation other than ACS.
* Pregnancy or women of childbearing potential who are not using an effective method of contraception
* Co-morbid condition with life expectancy less than 6 months
* Prior enrollment in one of the fondaparinux ACS trails or currently receiving an experimental pharmacologic agent
D: Inclusion Criteria:

* impaired left ventricular function (Ejection Fraction \< 30%)
* large area of myocardium at risk (BCIS-1 Myocardial Jeopardy Score ≥ 8/12)

Exclusion Criteria:

* cardiogenic shock
* acute STEMI within previous 48 hours
* complications of recent AMI (including ventricular septal defect, severe mitral regurgitation, intractable ventricular arrhythmias)
* contraindications to IABP use (including significant iliac or femoral arterial disease and more than mild aortic regurgitation)

Answer: C