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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00464087
First received: April 19, 2007
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndromes
Drug: Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Switching From Arixtra (Fondaparinux) to Angiomax (Bivalirudin) or Unfractionated Heparin in Patients With Acute Coronary Syndromes (ACS) Without ST-segment Elevation Undergoing Percutaneous Coronary Intervention (PCI): SWITCH III

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge [ Time Frame: During hospitalization, after Fondaparinux administration, prior to randomization ] [ Designated as safety issue: Yes ]
    Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)

  • The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge [ Time Frame: During hospitalization, after randomization, during PCI ] [ Designated as safety issue: Yes ]
    Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)

  • The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge [ Time Frame: During hospitalization, after PCI ] [ Designated as safety issue: Yes ]
    Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)


Secondary Outcome Measures:
  • Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis [ Time Frame: during index hospitalization ] [ Designated as safety issue: No ]
    Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis


Enrollment: 100
Study Start Date: June 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Heparin
Patients are switched from fondaparinux to heparin, receiving a dose of 60 U/Kg IV during the PCI
Drug: Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin
Active Comparator: 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.
Drug: Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464087

Locations
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
Canada, Quebec
Institut Universitaire de cardiologie et de Pneumologie de Québec (Hôpital Laval)
Québec City, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Medstar Research Institute
GlaxoSmithKline
Investigators
Principal Investigator: Ron Waksman, MD Washington Hospital Center, Washington, DC
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT00464087     History of Changes
Other Study ID Numbers: SWITCH III
Study First Received: April 19, 2007
Results First Received: April 16, 2013
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Bivalirudin
Calcium heparin
Fondaparinux
Heparin
Hirudins
PENTA
Anticoagulants
Antithrombins
Cardiovascular Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014