Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI (SWITCHIII)

Inclusion Criteria:

1. The patient is, male or female, > 18 years of age; 2. The patient presents with coronary syndrome, unstable angina or NSTEMI defined as at least one of the following criteria:

• Elevated creatine kinase MB or Troponin I or T (above ULN)

• ECG changes indicative of ischemia 3. The patient is scheduled for angiography, with possible angioplasty, evaluation of their coronary disease; 4. The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.

  1. ST elevated myocardial infarction within the preceding 48 hours;
  2. Patient weighs more than 400 lbs (181.2 kg) or less than 110 lbs (50 kg);
  3. Patients presenting on or received bivalirudin, GP IIb/IIIa inhibitors or low-molecular weight heparin within the preceding 24 hours;
  4. Patients that received unfractionated heparin less than or equal to 90 minutes prior to fondaparinux administration.
  5. Patients with known conditions of bleeding diathesis or actively bleeding within the previous 6 months (GI bleed etc.);
  6. Known diagnosis of acute bacterial endocarditis;
  7. Patients with cardiogenic shock or required IABP;
  8. If patient is on warfarin (Coumadin) therapy;
  9. Patients who had a major or minor stroke (CVA or TIA) or major surgery within the past 6 months;
  10. Known impaired renal function (creatinine ≥ 3.0 mg/dL (265.2 μmol/L),) status post renal transplant, patients on chronic dialysis or creatinine clearance ≤ 30 ml/min;
  11. A platelet count of less than 100,000 cells/mm3;
  12. Known allergies to fondaparinux, aspirin, clopidogrel bisulfate (PlavixR), ticlopidine (TiclidR), heparin, bivalirudin, or contrast that cannot be medically managed;
  13. Prior angioplasty within the previous 30 days;
  14. Contraindication to low-molecular weight heparin, unfractionated heparin or bivalirudin;
  15. Pregnant or lactating women;
  16. Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study;
  17. Currently participating in an investigational drug or another device study.