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

Primary Purpose

Acute Coronary Syndromes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bridgeport Hospital
  • Washington Hospital Center
  • Baptist Cardiac and Vascular Institute
  • Stony Brook University Medical Center
  • University of North Carolina-Chapel Hill
  • Hamilton General Hospital
  • Institut Universitaire de cardiologie et de Pneumologie de Québec (Hôpital Laval)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Heparin

Bivalirudin

Arm Description

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

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.

Outcomes

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
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
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
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
Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis

Full Information

First Posted
April 19, 2007
Last Updated
July 30, 2013
Sponsor
Medstar Health Research Institute
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00464087
Brief Title
Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI
Acronym
SWITCHIII
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heparin
Arm Type
Active Comparator
Arm Description
Patients are switched from fondaparinux to heparin, receiving a dose of 60 U/Kg IV during the PCI
Arm Title
Bivalirudin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin
Primary Outcome Measure Information:
Title
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
Description
Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)
Time Frame
During hospitalization, after Fondaparinux administration, prior to randomization
Title
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
Description
Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)
Time Frame
During hospitalization, after randomization, during PCI
Title
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
Description
Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)
Time Frame
During hospitalization, after PCI
Secondary Outcome Measure Information:
Title
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
Description
Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis
Time Frame
during index hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Waksman, MD
Organizational Affiliation
Washington Hospital Center, Washington, DC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Baptist Cardiac and Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
University of North Carolina-Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada
Facility Name
Institut Universitaire de cardiologie et de Pneumologie de Québec (Hôpital Laval)
City
Québec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

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

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