Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI
Condition: Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin
Intervention MeSH terms: Heparin; Calcium heparin; PENTA; Bivalirudin; Fondaparinux
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this clinical trial is to evaluate safety of switching from
      fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute
      coronary syndrome undergoing percutaneous coronary angioplasty.
    

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.