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

NCT ID: NCT00464087

Last Updated: 2013-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-11-30

Brief 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.

Detailed Description

This is a prospective open label, randomized, multi-center registry. One hundred patients who received fondaparinux within the 24 hours prior to presentation to the coronary catheterization lab and who are suitable for percutaneous coronary intervention. The patients will be randomized in a 1:1 fashion to either unfractionated heparin or bivalirudin during the angioplasty. All patients will be followed throughout the duration of the hospital stay.

Conditions

Acute Coronary Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heparin

Patients are switched from fondaparinux to heparin, receiving a dose of 60 U/Kg IV during the PCI

Group Type: ACTIVE_COMPARATOR

Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin

Intervention Type: DRUG

Bivalirudin

Patients switched from fondaparinux to bivalirudin, received a bolus of 0.75 mg/kg IV followed by infusion of 1.75 mg/g per hour infusion during the PCI.

Group Type: ACTIVE_COMPARATOR

Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin

Intervention Type: DRUG

Interventions

Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Waksman, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Hospital Center, Washington, DC

Locations

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

Countries

United States; Canada

Other Identifiers

SWITCH III

Identifier Type: -

Identifier Source: org_study_id