Clinical trial NCT00464087 (phase 3, status: completed)
Conditions: acute coronary syndromes
ICD codes: I24.0
Drugs: switching from fondaparinux to bivalirudin or unfractionated heparin
SMILES: CO[C@H]1O[C@H](COS(O)(=O)=O)[C@@H](O[C@@H]2O[C@H]([C@@H](O[C@H]3O[C@H](COS(O)(=O)=O)[C@@H](O[C@@H]4O[C@@H]([C@@H](O[C@H]5O[C@H](COS(O)(=O)=O)[C@@H](O)[C@H](O)[C@H]5NS(O)(=O)=O)[C@H](O)[C@H]4O)C(O)=O)[C@H](OS(O)(=O)=O)[C@H]3NS(O)(=O)=O)[C@H](O)[C@H]2OS(O)(=O)=O)C(O)=O)[C@H](O)[C@H]1NS(O)(=O)=O
Eligibility criteria:

        Inclusion Criteria:

        1. The patient is, male or female, > 18 years of age; 2. The patient presents with coronary
        syndrome, unstable angina or non ST segment elevated myocardial infarction (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 intra-aortic balloon pump (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.