DRUG
Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI
Status
Completed
Phase
Phase 3
Enrollment
100
Locations
7
Results
Posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Apr 20, 2007
Study start
Jun 2007
Primary completion
Nov 2010
Study completion
Nov 2010
Results posted
Aug 1, 2013
Registry updated
Aug 1, 2013
Outcomes
What the study measures.
Primary outcomes
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
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
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
Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)
Secondary outcomes
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
Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
7 registered sites.
Canada · United States. Showing up to 24 locations stored in the fast local snapshot.
Bridgeport Hospital
Bridgeport, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States
Hamilton General Hospital
Hamilton, Ontario, Canada
Institut Universitaire de cardiologie et de Pneumologie de Québec (Hôpital Laval)
Québec, Quebec, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Bivalirudin.
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Duke University · Coronavirus Infection (COVID-19) · Pulmonary Arterial Hypertension
Not applicable
Recruiting
5,000
2026-07
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
Sydney Local Health District · Extracorporeal Membrane Oxygenation Complication
Phase 2
Recruiting
80
2026-05
Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation
Xiaotong Hou · Extracorporeal Membrane Oxygenation Complication
Not applicable
Recruiting
154
2026-04
Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes
Shenyang Northern Hospital · Percutaneous Coronary Intervention · High Bleeding Risk
Phase 4
Not yet recruiting
5,270
2026-02
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
Stanford University · Heart Failure · Cardiogenic Shock
Phase 2
Recruiting
50
2026-01
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
NYU Langone Health · Coronary Microvascular Disease · Ischemic Heart Disease
Not applicable
Active, not recruiting
206
2025-11
Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI
Shenyang Northern Hospital · ST Elevation Myocardial Infarction
Not applicable
Completed
6,016
2025-08
A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.
Peking University First Hospital · Coronary Microvascular Dysfunction
Phase 4
Recruiting
70
2025-08
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.