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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndromes
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L2X2
      • Hamilton General Hospital
  • Quebec
    • Québec City, Quebec, Canada, G1V 4G5
      • Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)
• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Cardiac and Vascular Institute
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina-Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)	During hospitalization, after Fondaparinux administration, prior to randomization
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	Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)	During hospitalization, after randomization, during PCI
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	Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)	During hospitalization, after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis	during index hospitalization

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Ron Waksman, MD, Washington Hospital Center, Washington, DC

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: April 19, 2007
• First Submitted That Met QC Criteria: April 19, 2007
• First Posted (Estimate): April 20, 2007

Study Record Updates

• Last Update Posted (Estimate): August 1, 2013
• Last Update Submitted That Met QC Criteria: July 30, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Bivalirudin; Calcium heparin; Fondaparinux; PENTA
• Other Study ID Numbers: SWITCH III