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

Acute Coronary Syndromes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464087
• Other study ID #: SWITCH III
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2007
• Last updated: July 30, 2013
• Start date: June 2007
• Est. completion date: November 2010

Study information

• Verified date: July 2013
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes

Intervention

Drug:
• Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Research Institute	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	No