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

NCT00464087 | Completed Phase 3 Results DMC

• 1 other identifier: SWITCH III
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 7

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.

Conditions

Acute Coronary Syndromes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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

  during index hospitalization

Study Arms (2)

Heparin

ACTIVE COMPARATOR

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

Bivalirudin

ACTIVE COMPARATOR

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

Interventions

Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin DRUG

Bivalirudin; Heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• GlaxoSmithKline: collaborator

Study Sites (7)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

Institut Universitaire de cardiologie et de Pneumologie de Québec (Hôpital Laval)

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Heparin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

This trial included only small number of patients and is not powered to detect intergroup differences

Results Point of Contact

• Title: Ron Waksman, MD
• Organization: Medstar Health Research Institute

ron.waksman@medstar.net

202-877-2812

Study Officials

• Ron Waksman, MD

  Washington Hospital Center, Washington, DC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 20, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 1, 2013
• Results First Posted: August 1, 2013

Record last verified: 2013-07

Locations

US (5); CA (2)