Please select the eligibility criteria that correspond to the clinical trial below.
Title: The ACUITY Trial: A Randomized Comparison of Angiomax (Bivalirudin) Versus Heparin (Unfractionated Heparin or Enoxaparin) in Patients Undergoing Early Invasive Management for Acute Coronary Syndromes Without ST-Segment Elevation
Brief Summary: The purpose of this study is to show that, when compared with heparin (enoxaparin or unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the time of percutaneous coronary intervention \[PCI\]; Arm A):

1. Bivalirudin with routine GPIIb/IIIa inhibition (either started upfront or at the time of PCI; Arm B) provides non-inferior or superior overall clinical outcomes and
2. Bivalirudin alone (Arm C) reduces clinically significant bleeding. An important secondary objective for this comparison is to show that bivalirudin is not inferior for ischemic complications.


Options:
A: Inclusion Criteria:

1. Be aged \>=18 years at the time of randomization.
2. Have symptoms which include at least 10 minutes of angina or anginal equivalent that the investigator believes has a high likelihood of being ischemic in origin within the 24 hours prior to randomization consistent with a diagnosis of Unstable Angina/Non-ST Elevation Myocardial Infarction (UA/NSTEMI) (patients with symptoms atypical for cardiac ischemia should not be enrolled).
3. Meet at least one of the following criteria for UA/NSTEMI:

   1. All of the following four features: \*Age \>= to 65 years; \*aspirin taken within the last 7 days; \*two or more episodes of angina in the last 24 hours; \*three or more of the following risk factors: hypertension, high cholesterol, family history, diabetes, current smoker OR
   2. ECG changes: New or presumably new ST-segment depression \>=0.1 MV (\>=1mm), or transient (\<30 minutes) ST-segment elevation \>=0.1MV (\>=1mm) in at least 2 contiguous leads, OR
   3. Abnormal cardiac enzymes within the 24 hours before enrollment defined as elevated troponin I, T or creatine phosphokinase-MB isoenzyme (CPK-MB) level greater than the site's upper limit of normal (ULN) OR
   4. History of coronary artery disease with documentation of one of the following: \*prior angiography (coronary stenosis of \>50%); \*prior PCI or Coronary Artery Bypass Grafting (CABG); \*prior definite, documented myocardial infarction.
4. Provide written informed consent before initiation of any study related procedures.

Exclusion Criteria:

1. Anticipated inability to perform angiography within 72 hours of randomization and anticipated inability to perform any intervention required (PCI or CABG) within the index hospitalization.
2. ST segment elevation of \>1 mm in 2 contiguous ECG leads lasting for \>30 minutes, or new left bundle branch block, or a clinical syndrome consistent with acute evolving transmural MI requiring immediate thrombolytic or interventional reperfusion therapy.
3. Cardiogenic shock (systolic blood pressure \<80 mmHg for \>30 minutes not responding to intravenous fluids, or requiring intravenous pressor agents or an intra-aortic balloon pump).
4. Bleeding diathesis or any history of hemorrhagic stroke or other intra-cerebral bleed, cerebral arteriovenous malformation, cerebral aneurysm or prior ischemic stroke within the last 2 years, or any prior stroke with residual neurologic deficit. Gastrointestinal or genitourinary bleeding within the last 2-weeks.
5. Platelet count \<100,000 cells/mm3 at baseline, or history of heparin induced thrombocytopenia
6. Patients on warfarin or phenprocoumon, unless they can be safely discontinued and the baseline INR is \< 1.5 times control.
7. Allergy to pork or pork products.
8. Patients who have been started on and received 2 or more doses of low molecular weight heparin for the current admission prior to randomization (patients who have received one dose of low molecular weight heparin may still be enrolled.
9. Patients who have been started on bivalirudin in the 6 hours prior to randomization
10. Thrombolytic therapy or abciximab use within the last 24 hours.
11. Treatment with a GPIIb/IIIa inhibitor at the time of randomization, which cannot be discontinued.
12. Patients on Arixtra (fondaparinux).
13. Absolute contraindication or allergy to:

    * any one of enoxaparin, unfractionated heparin, bivalirudin or aspirin
    * both abciximab and eptifibatide
    * both eptifibatide and tirofiban
    * iodinated contrast which cannot be pre-medicated
14. Contraindications to angiography, including but not limited to severe peripheral vascular disease.
15. Angina from secondary causes.
16. Pregnancy or nursing mothers. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
17. Calculated serum creatinine clearance \< 30 mL/min (Determined by the Cockcroft Gault formula: ((140-age in yrs) x weight in kg)/(814.464 x Creatinine in mmol/l) or /(72 x \[Creatinine in mg/dL\]). For women, multiply by 0.85.
18. Previous enrollment in this study.
19. Patients currently enrolled in another investigational drug study that has not completed the follow-up phase.
B: Inclusion Criteria:

Patients with ST-segment elevation acute myocardial infarction with all of the following criteria will be eligible for enrollment:

1. Age \>18 years.
2. Chest discomfort \>30 minutes with no response to nitroglycerin.
3. Time from the onset of symptoms to randomization \< 12 hours.
4. ST segment elevation \> 1 mm in two or more limb leads or 2 mm in two or more contiguous precordial leads or non-diagnostic ECG (left bundle branch block or pacemaker rhythm) with classic symptoms.
5. Killip class \> 3.
6. Written informed consent will be obtained.

Exclusion Criteria:

Patients presenting with any of the following will not be included in the study.

1. Cardiogenic shock defined as a systolic blood pressure \<90 mm Hg without response to fluid administration or \<100 mmHg in patients with supportive treatment and no bradycardia.
2. Suspected mechanical complications of acute myocardial infarction.
3. Previous CABG.
4. Non-cardiac disease that is likely to jeopardize the planned termination of the study.
5. Woman of childbearing potential unless a negative pregnant test.
6. Active bleeding and recent (within 2 weeks) surgery that contraindicate the use of heparin, tirofiban, or platelet aggregation inhibitors.
7. Contraindications for thrombolytic use.

   * previous hemorrhagic stroke at any time
   * history of prior non-hemorrhagic cerebrovascular accident within 12 months
   * intracerebral neoplasia
   * active internal bleeding
   * suspected aortic dissection
   * Uncontrolled hypertension \>180/110 in several measurements
   * any other known intracerebral pathology not covered in contraindications
   * Current use of anticoagulants or heparin use within 8 hours
   * known bleeding diathesis
   * recent trauma (\< 4 weeks), including head trauma or traumatic or prolonged (\>10 minutes) CPR or recent major surgery or biopsy (\<8 weeks)
   * noncompressible vascular punctures
   * recent (\< 4 weeks) internal bleeding
   * pregnancy
   * active peptic ulcer
8. History of hypersensitivity to aspirin, ticlopidine, clopidogrel, heparin, tirofiban and stainless steel.
9. Known renal failure, creatinine \>2,5 mg/dL.
10. Known impaired hepatic function that contraindicates the use of clopidogrel.
11. Known thrombocytopenia (100.000).
12. Participation in other trial.
13. Known multivessel disease identified as no suitable for revascularization.
14. Known peripheral vascular disease that difficult cardiac catheterization.
C: Inclusion Criteria:

* ST segment elevation myocardial infarction
* Schedule for primary percutaneous coronary intervention
* Informed consent

Exclusion Criteria:

* Administration of fibrinolytic or any GP IIb/IIIa inhibitors for the treatment of current acute myocardial infarction or within 1 month before it
* History of bleeding diathesis or allergy to the studies drug
* Major surgery within 30 days
* Limited life expectancy, e.g. neoplasms, others
* Pregnancy
D: Inclusion Criteria:

A) low restenosis risk based on angiographic findings defined as follows:

----patients will be considered at low restenosis risk if no planned stent lower than 3.0 mm is intended to be implanted in lesions expect left main or vein graft

B) high bleeding risk and/or presence of relative-absolute contraindication to dual anti-platelet treatment beyond 30 days defined as follows:

1. Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents
2. Recent (within previous 12 months) bleeding episode(s) which required medical attention
3. Previous bleeding episode(s) which required hospitalization if the bleeding diathesis has not been completely resolved (i.e. surgical removal of the bleeding source)
4. Age greater than 80
5. Systemic conditions associated to increased bleeding risk (e.g. hematological disorders or any known coagulopathy determining bleeding diathesis, including history of or current thrombocytopenia defined as platelet count \<100,000/mm3 (\<100 x 109/L).
6. Known Anemia defined as repeatedly documented hemoglobin lower than 10 gr/dl which is not due to an acute and documented blood loss
7. Need for chronic treatment with steroids or NSAID

C) Patients at high thrombosis risk based on the presence of at least one of the following criteria:

1. Allergy/intolerance to aspirin
2. Allergy/intolerance to clopidogrel AND ticlopidine
3. Planned surgery (other than skin) within 12 months of percutaneous coronary intervention (PCI).
4. patient with cancers (other than skin) and life expectancy \>1 year
5. Patients with systemic conditions associated with thrombosis diathesis (e.g., hematologic disorders and any known systemic conditions determining a pro-thrombotic state including immunological disorders)

   -

   Exclusion Criteria:
   * Any of the following:

     1. Women who are pregnant. Women of childbearing potential must have a negative pregnancy test (urine or serum HCG) within 7 days prior to randomization; as close to randomization as possible, within 24 hours preferred.
     2. Subjects who are unable to give informed consent and assurance for complete contact through 12 months.
     3. PCI with stenting in the previous 6 months

Answer: A