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

Completed · Phase 3

Conditions studied: Acute Coronary Syndromes

In brief

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.

Key facts

Study ID

NCT00464087

Run by

Medstar Health Research Institute

People needed

100

Starts

2007-06-01

Expected to finish

2010-11-01

Last updated by the study team

2013-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• ST elevated myocardial infarction within the preceding 48 hours;
• Patient weighs more than 400 lbs (181.2 kg) or less than 110 lbs (50 kg);
• Patients presenting on or received bivalirudin, GP IIb/IIIa inhibitors or low-molecular weight heparin within the preceding 24 hours;
• Patients that received unfractionated heparin less than or equal to 90 minutes prior to fondaparinux administration.
• Patients with known conditions of bleeding diathesis or actively bleeding within the previous 6 months (GI bleed etc.);
• Known diagnosis of acute bacterial endocarditis;
• Patients with cardiogenic shock or required intra-aortic balloon pump (IABP)
• If patient is on warfarin (Coumadin) therapy;
• Patients who had a major or minor stroke (CVA or TIA) or major surgery within the past 6 months;
• 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;
• A platelet count of less than 100,000 cells/mm3;
• Known allergies to fondaparinux, aspirin, clopidogrel bisulfate (PlavixR), ticlopidine (TiclidR), heparin, bivalirudin, or contrast that cannot be medically managed;
• Prior angioplasty within the previous 30 days;
• Contraindication to low-molecular weight heparin, unfractionated heparin or bivalirudin;
• Pregnant or lactating women;
• Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study;
• Currently participating in an investigational drug or another device study.

Where it is running

• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Baptist Cardiac and Vascular Institute — Miami, Florida, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• University of North Carolina-Chapel Hill — Chapel Hill, North Carolina, United States
• Hamilton General Hospital — Hamilton, Ontario, Canada
• Institut Universitaire de cardiologie et de Pneumologie de Québec (Hôpital Laval) — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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